Health Studies MN

Within 


Search Results

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

3802 Study Matches

Sorting by: Relevance Distance

A PhAse 1a/b, Dose finding, open-label study to eValuate sAfety and toxicity, of iNtravesiCal instillation of TARA-002 in adults with high-gradE non-muscle invasive blaDder cancer (ADVANCED-1)

Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade, Non-muscle Invasive Bladder Cancer

Paras Shah
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306123-P01-RST
22-000182
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Male or female subjects 18 years of age or older at the time of signing the informed
consent

- Subjects who have voluntarily given written informed consent after the nature of the
study has been explained according to applicable requirements prior to study entry

- Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with
concomitant Ta) urothelial cell carcinoma of the bladder on central review

- Subjects who are treatment naïve, are unable to obtain intravesical BCG for the
treatment of NMIBC, have received at least one dose of intravesical BCG, or at least
one dose of intravesical chemotherapy


Exclusion Criteria:


- Penicillin allergy (subjects with a questionable history of allergy to penicillin or
no history of penicillin use will undergo penicillin blood allergy testing prior to
inclusion in the study)

- Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or
histological variants including plasmacytoid, sarcomatoid, or squamous components
according to central review

- Concomitant prostatic or upper tract urothelial involvement, per Investigator's
assessment

- Nodal involvement or metastatic disease that existed at any time (past or present
disease)

- Bladder cancer stage ≥ T1 within the last 36 months according to central histology
review

- Bladder cancer stage CIS with concomitant T1

For more information on eligibility criteria, please contact the sponsor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Comparison of Variable Motivational Interviewing Frequency Augmented by Wearable Tracker for Meeting Personalized Wellness Goals

Personalized Wellness Goals Comparison of Variable Motivational Interviewing Frequency Augmented by Wearable Tracker

Brian Dougan
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308349-H01-RST
22-005984
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients being seen in the Executive Health Clinic at Mayo Clinic in Rochester.
  • Patients 8 years of age or older.
  • Patients able to provide informed consent.
  • Patients able to complete all aspects of this trial.


Exclusion Criteria:

  • Participation in another organized wellness program.
  • Participants who refuse to use the wearable tracker, connect with the Wellness Coach or cannot complete the online data collection surveys.
  • An unstable medical or mental health condition as determined by the physician investigator.

Eligibility last updated 6/8/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Impact of POCUS and artificial intelligence-enabled electrocardiogram on detection of asymptomatic patients with aortic stenosis.

Function of Artificial Intelligence-enabled Electrocardiogram in Early Detection of Patients With Aortic Stenosis

Jae Oh
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-308568-H01-RST
22-006522
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • ≥ 18 years of age.
  • Patients with positive AI-ECG for AS within 1 year or current will be retrospectively and prospectively identified.


Exclusion Criteria:
 

  • Patients with previous valve surgery, permanent pacemaker, active infective endocarditis, or those who have already been diagnosed as AS.

Eligibility last updated 6/20/22. Questions regarding updates should be directed to the study team contact.

Diagnostic Test
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

State Representation in Early Psychosis - Project 4 (STEP (P4))

All
15 Years to 45 Years old
N/A
This study is also accepting healthy volunteers
NCT05664594
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• English proficiency, as determined by staff observation and participant self-report
• Estimated IQ at or above 70, as estimated by the cognitive assessments Additional Inclusion Criteria for Early Psychosis Participants:
• Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis, with onset of psychotic symptoms within the previous 5 years
• Achieved clinical stability, defined as outpatient status for at least one month prior to study participation plus clinically stable doses of psychiatry medications for at least one month prior to study participation
Exclusion Criteria:

• Unable or unwilling to provide informed consent
• The participant is unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
• Participant is pregnant
• Participant is illiterate
• Cannot pass the CMRR Subject Safety Screen due to MRI contraindications
• Presence of a major neurological disorder
• Previous clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-Is
• Meets criteria for substance or alcohol dependence within 3 months of enrollment
• The presence of any major medical condition that, in the opinion of the PI/Co-Is, would impede participation in the study or would put the participant at additional risk by participating Additional Exclusion Criteria for Early Psychosis Participants:
• Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is
• Meets criteria for clinical risk of suicidal behavior, as defined by: Clinician judgement
• A suicide attempt within 6 months of enrollment
• Active suicidal ideation at screening or baseline, as indicated by the C-SSRS
• Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment, as indicated by the C-SSRS Additional Exclusion Criteria for Control Participants:
• Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorder
• Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder
Device: Computerized Cognitive Training
Psychosis, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Schizoaffective Disorder
Cognitive Training, Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), State Representation
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Hide all locations

Location Contacts
University of Minnesota — Minneapolis, Minnesota Liberty Holmberg Kohler - (step-phase2@umn.edu)

A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED)

All
18 Years and over
Phase 3
This study is also accepting healthy volunteers
NCT05176639
Show full eligibility criteria
Hide eligibility criteria
Key Inclusion Criteria for Healthy Volunteers:
• Must be free of clinically significant disease or medical conditions as determined by the Investigator
• Female volunteers must not be of child-bearing potential Key Exclusion Criteria for Healthy Volunteers: ∙ Must not have a history of or any evidence of diabetes mellitus, recently diagnosed renal impairment or inflammatory bowel disease, or clinically significant ear pathology or earing impairment Key Inclusion Criteria for Participants with TED in Phase 1/2 MAD cohorts:
• Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 1 year prior to screening OR moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began over 1 year prior to screening
• Must have active TED and a Clinical Activity Score (CAS) of ≥ 4 on the 7-item scale for the study (more proptotic) eye OR chronic TED with no CAS requirement
• Must agree to use highly effective contraception as specified in the protocol
• Female TED participants must have a negative serum pregnancy test Key Exclusion Criteria for Participants with TED in Phase 1/2 MAD cohorts:
• Must not have received prior treatment with another anti-IGF-1R monoclonal antibody
• Must not have used oral corticosteroids within 4 weeks prior to Day 1
• Must not have received rituximab, tocilizumab or other immunosuppressive agents within 90 days prior to Day 1
• Must not have evidence of optic nerve involvement within the previous 6 months
• Must not have corneal decompensation in the study eye unresponsive to medical management
• Must not have had previous orbital irradiation or surgery for TED in the study eye
• Must not have a history inflammatory bowel disease Must not have clinically significant ear pathology or hearing impairment
• Must not have received an investigational agent for any condition within 60 days
• Female TED participants must not be pregnant or lactating Key Inclusion Criteria for Participants with TED in Phase 3 study:
• Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
• Must have Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study (more proptotic) eye
• Must agree to use highly effective contraception as specified in the protocol
• Female TED participants must have a negative serum pregnancy test Key Exclusion Criteria for Participants with TED in Phase 3 study:
• Must not have received prior treatment with another anti-IGF-1R monoclonal antibody
• Must not have used oral corticosteroids within 2 weeks prior to Day 1
• Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
• Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
• Must not have had previous orbital irradiation or surgery for TED in the study eye
• Must not have a history inflammatory bowel disease
• Must not have a history or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing l loss
• Must not have received an investigational agent for any condition
• Female TED participants must not be pregnant or lactating
Drug: VRDN-001 Phase 1/2 MAD (HV and TED), Drug: VRDN-001 Phase 3 Cohort (THRIVE), Drug: VRDN-001 Placebo
Thyroid Eye Disease
Graves Ophthalmopathy, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Hide all locations

Location Contacts
University of Minnesota Eye Clinic — Minneapolis, Minnesota Andrew Harrison

Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE (EMERALD)

All
6 Months to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05001737
Show full eligibility criteria
Hide eligibility criteria
Inclusion criteria Run-in phase in all cohorts 1. Informed consent provided by the subject or by the subject s' legally authorized representative(s) with the assent of subjects who are legally capable of providing it, as required by local law. 2. Male and female subjects aged between 6 months and 80 years of age at the time of diagnosis of MAS. 3. MAS defined as per the criteria defined below for each cohort and requiring treatment with GCs. Interventional phase in all cohorts 1. Informed consent provided by the subject or by the subject's legally authorized representative(s) with the assent of subjects who are legally capable of providing it, as as required by local law. 2. Male and female subjects aged between 6 months and 80 years of age at the time of diagnosis of active MAS. 3. Subjects who have shown an inadequate response to high dose intravenous (i.v.) GCs administered for at least 3 days according to local standard clinical practice, including but not limited to pulses of 30 mg/kg PDN on 3 consecutive days. High i.v. GCs dose is recommended not to be lower than 2 mg/kg/ day PDN equivalent (or at least 60 mg/day in pediatric subjects of 30 kg or more, and at least 1g/day in adult MAS subjects). In case of rapid worsening of the subject's condition and/or laboratory parameters, as per Investigator judgment, inclusion may occur within less than 3 days from starting high dose GCs. 4. Diagnosis of active MAS confirmed by the treating rheumatologist, having ascertained the followings: a. Febrile subjects presenting with ferritin > 684 ng/mL. b. and any 2 of: i. Platelet count ≤ 181 x109/L ii. AST-level > 48 U/L iii. Triglycerides > 156 mg/dL iv. Fibrinogen level ≤ 360 mg/dL 5. Female subjects of child-bearing potential willing to use highly effective methods of contraception from study drug initiation to 6 months after the last dose of study drug. Specific inclusion criteria to Cohort 1 and Cohort 2 6. Cohort 1: 1. Confirmed sJIA diagnosis. For subjects presenting with MAS in the context of the onset of sJIA, high presumption of sJIA will suffice for eligibility. 2. Confirmed diagnosis of AOSD as per Yamaguchi criteria. 7. Cohort 2: 1. Confirmed diagnosis of SLE as per SLICC'12 criteria. Exclusion criteria 1. Primary HLH documented by either the presence of a known causative genetic mutation or abnormal perforin expression and CD107a degranulation assay as described with primary hemophagocytic lymphohistiocytosis or by the presence of family history. 2. Confirmed malignancy. Note: subjects with a suspected malignancy should have mononuclear cells typed by flow cytometry and/or tissue biopsy, as applicable, to rule out malignancy. 3. Treatment with canakinumab, JAK inhibitors, TNF inhibitors and tocilizumab at the time of emapalumab initiation. 4. Ongoing treatment with anakinra at a dose above 4 mg/kg at time of emapalumab initiation. 5. Subjects treated with etoposide for MAS in the last 1 month. 6. Clinically active mycobacteria (typical and atypical), Histoplasma Capsulatum, or Salmonella infections. 7. Evidence of leishmania infections. 8. Evidence of latent tuberculosis. 9. History of hypersensitivity or allergy to any component of the study drug. 10. Receipt of a Bacillus Calmette-Guerin (BCG) vaccine within 12 weeks prior to screening. 11. Receipt of a live or attenuated live (other than BCG) vaccine within 4 weeks prior to screening. 12. Pregnancy or lactating female subjects.
Drug: Emapalumab
Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus, SJIA, AOSD, MAS
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Hide all locations

Location Contacts
University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota Dr. Binstadt, MD

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) (SOTERIA)

All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04796337
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
• Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
• Must have the ability to understand and provide documented informed consent
• Females of childbearing potential must:
• Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
• If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug
• Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug
• Male participants must:
• Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
• Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug
• Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study
Exclusion Criteria:

• Did not participate in a sotatercept PAH parent trial
• Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
• Presence of an ongoing serious adverse event (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
• Pregnant or breastfeeding females
Biological: Sotatercept
Pulmonary Arterial Hypertension, PAH
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Hide all locations

Location Contacts
University of Minnesota ( Site 1062) — Minneapolis, Minnesota Study Coordinator

A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)

Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)

Elie Naddaf
All
18 years to 65 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-308418-P01-RST
22-006033
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Patients must be between 18 and 65 years of age, inclusive, at the time of consent

- Genetically confirmed diagnosis of FSHD 1 or FSHD 2.

- Clinical severity score of 2 to 4 (Ricci Score; Range 0-5), at screening. Patients who are wheelchair-dependent or dependent on walker or wheelchair for activities are not
permitted to enroll in the study.

- Screening total relative surface area (RSA) (Q1-Q4) without weight in the dominant upper extremities (UE) assessed by reachable workspace (RWS) ≥ 0.2 and ≤ 0.7.

- No contraindications to MRI.


Exclusion Criteria:


- Previously diagnosed cancer that has not been in complete remission for at least 5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix that have been resected or ablated for cure are not exclusionary.

- Patients who are on drug(s) or supplements that may affect muscle function, as determined by the Investigator: patients must be on a stable dose of that drug(s) or supplement for at least 3 months prior to the first dose of study drug and remain on that stable dose for the duration of the study.

- Orally administered CYP3A4 substrates and MATE and OAT3 substrates are not permitted as concomitant therapy during the administration of losmapimod (defined as baseline
visit through end of study treatment).

- Known active opportunistic or life-threatening infections including HIV and hepatitis B or C.

- Known active or inactive tuberculosis infection.

- Acute or chronic history of liver disease.

- Known severe renal impairment.

- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s); or history or evidence of abnormal ECGs.

- Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or currently participating in a study of an investigational device.

- Current or anticipated participation in a natural history study. Previous participation is allowed but patients cannot continue after enrollment in Study 1821-FSH-301.

- Known hypersensitivity to losmapimod or any of its excipients.

- Previous participation in a Fulcrum-sponsored FSHD losmapimod study (FIS-001-2019 or FIS-002-2019).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/9/23. Questions regarding updates should be directed to the study team contact.

Other, Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04798261
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less 2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram 3. Frontline endovascular treatment with the Indigo Aspiration System per IFU 4. Patient is ≥ 18 years of age 5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion Criteria:
1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin) 2. Stage III/IV cancer or cancer which requires active chemotherapy during the course of the study 3. Known serious, uncontrolled sensitivity to radiographic agents 4. Life expectancy < 180 days 5. Patients on ECMO 6. Pregnant patients 7. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies 8. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Device: Indigo Aspiration System
Pulmonary Embolism
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Hide all locations

Location Contacts
University of Minnesota — Minneapolis, Minnesota

Phase 1 Study of E6201 plus Dabrafenib for the Treatment of Central Nervous System (CNS) Metastases from BRAF V600- Mutated Metastatic Melanoma (E6201-01)

E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS)

Svetomir Markovic
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305152-P01-RST
22-000531
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Age >= 18 years

- Histologically or cytologically confirmed stage IV metastatic BRAF V600-mutated melanoma

- Documented metastasis of the primary tumor to the CNS

- BRAF-mutation melanoma tumor status will be established prior to entry based on previous BRAF-gene analysis reports from a Clinical Laboratory Improvement Act (CLIA)
qualified laboratory. If a report is not available, the mutation analysis will be performed at screening on archival tissue

- At least one measurable brain metastasis 0.5
•3.0 cm, as assessed by magnetic resonance imaging (MRI) or computed tomography (CT) with contrast =< 3 weeks prior to
registration and does not require immediate local intervention (surgery or radiosurgery) NOTE: Tumor lesions in a previously irradiated area are not considered
measurable disease; disease that is measurable by physical examination only is not eligible

- Asymptomatic or symptomatic CNS metastasis

- Other metastatic melanoma systemic disease is allowed, including leptomeningeal disease

- Prior stereotactic radiosurgery and/or excision of up to 3 brain metastases is allowed > 3 weeks before initiation of study treatment, provided neurological sequelae have
resolved completely and at least one measurable metastasis with documented disease progression is present on MRI

- Prior immunotherapy for metastatic disease is allowed, if >= 2 weeks have elapsed between the end of therapy and initiation of study treatment

- Prior treatment with BRAF/MEK inhibitor therapy is allowed, if >= 2 weeks have elapsed between the end of therapy and initiation of study treatment

- Prior melanoma adjuvant immunotherapy is allowed, if >= 6 months has elapsed between the end of therapy and initiation of study treatment

- Prior melanoma adjuvant BRAF/MEK inhibitor treatment is allowed if >= 12 months has elapsed between the end of therapy and initiation of study treatment

- Able to swallow and retain oral medication with no clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels

- Stable dose of corticosteroids for CNS metastasis is allowed if >= 7 days

- Seizures due to CNS metastases must be controlled with stable anti-epileptic treatment for >= 14 days

- Bisphosphonates and/or denosumab are allowed

- Life expectancy >= 3 months

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

- Hemoglobin (Hb) >= 9 g/dL without ongoing transfusional support (obtained =< 15 days prior to registration)

- Absolute neutrophil count (ANC) >= 1.0 x 10^9 cells/L without ongoing transfusional support (obtained =< 15 days prior to registration)

- Platelets >= 75 x 10^9 cells/L without ongoing transfusional support (obtained =< 15 days prior to registration)

- Creatinine =< 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance >= 50 mL/minute per the Cockcroft-Gault formula (obtained =< 15 days prior
to registration)

- Total bilirubin =< 2 times ULN unless due to Gilbert's disease (obtained =< 15 days prior to registration)

- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 2.5 times ULN, or <
5 times ULN for subjects with liver metastases (obtained =< 15 days prior to registration)

- Negative serum pregnancy test done =< 14 days prior to registration, for persons of childbearing potential only, defined as a female who has not undergone a hysterectomy
or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months)

- Willing to use contraception

- Sexually active persons of childbearing potential (PCBP) and persons able to father a child must agree to use adequate methods to avoid pregnancy throughout the study and for 28 days after the completion of study treatment

- Provide written informed consent

- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

- Ability to complete Patient Medication Diaries by themselves or with assistance

- Willingness to have institution procure previous BRAF-gene analysis report(s) from a CLIA qualified laboratory, or if a report is not available, willingness to have institution procure archived tumor sample to establish BRAF-mutational melanoma tumor status prior to study

- Ability to swallow


Exclusion Criteria:


- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

- Urgent need of treatment to prevent acute neurologic deterioration, including urgent neurosurgery or radiotherapy

- Symptoms of uncontrolled intracranial pressure

- Symptomatic or untreated spinal cord compression

- Prior treatment with any chemotherapeutic or investigational agent for =< 4 weeks prior to registration

- Prior treatment with > 2 lines of immunotherapy for metastatic disease 

- Prior treatment with > 1 line of a BRAF and/or MEK inhibitor for metastatic disease  

- Serious cardiac condition =< 6 months prior to registration, such as uncontrolled arrhythmia, myocardial infarction, unstable angina, or heart disease defined by the
New York Heart Association (NYHA) class III or class IV

- Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment

- Uncontrolled intercurrent non-cardiac illness including, but not limited to:

- Ongoing or active infection requiring IV antibiotic usage within the last week prior to study treatment

- Any other conditions that would limit compliance with study requirements or confound the interpretation of study results

- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy

- NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial

- Any of the following, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:

- Pregnant persons

- Nursing persons

- Persons of childbearing potential who are unwilling to employ adequate contraception

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/28/23. Questions

Drug, Administration of antineoplastic agent, Drug therapy
Stage 4 melanoma, Brain metastasis, Cancer, Central nervous system disorder, Melanoma, Metastatic melanoma, Skin cancer
Cancer treatment, Central nervous system, Dabrafenib [USAN:INN], E-6201, Integumentary system, Malignant melanoma with BRAF V600E mutation, Medical Oncology, Nervous system, Targeted drug therapy, dabrafenib, Dabrafenib
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

RNS® System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study (NAUTILUS)

RNS® System NAUTILUS Study

Jamie VanGompel
All
12 years and over
Phase 3, Feasibility
This study is NOT accepting healthy volunteers
2022-307786-P01-RST
22-003576
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Participant is age 12 and older.
  • Participant is male or is a female of childbearing potential who is surgically sterile, 2 years postmenopausal, or practices a reliable method of contraception (hormonal, barrier method or abstention).
  • Participant failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator. • Participant is able to maintain an electronic diary alone or with the assistance of a competent individual.
  • Participant is able to attend clinic appointments in accordance with the study schedule.
  • Participant or parent(s) or legal representative have signed an IRB approved written informed consent/assent. The informed consent form or specific assent form, where required, will be signed and dated by minors.
  • Participant is not currently implanted with an RNS Neurostimulator or NeuroPace Leads.
  • In the investigator’s opinion, participant is able to tolerate a neurosurgical procedure.
  • Participant with a confirmed diagnosis of idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures, with or without myoclonic or absence seizures, consistent with the International League against Epilepsy Revised Classification of Seizures (2017).
  • In the Investigator’s opinion, participant is expected to have 2 or more generalized tonic-clonic seizures during the combined two month retrospective and the 1 month prospective baseline. • Participant has had a routine electroencephalogram (EEG) prior to enrollment with electroencephalographic features consistent with idiopathic generalized epilepsy; other concomitant anomalies must be explained by adequate past medical history.
  • Participant has been on a stable antiseizure medication (ASM) regimen during the two month retrospective baseline and is willing to remain on a stable ASM regimen during the prospective Baseline and throughout the Effectiveness Evaluation Period, if medically possible; rescue benzodiazepine medications for acute seizure clusters are permitted.
  • Participant has undergone computed tomography (CT) or magnetic resonance imaging (MRI) within 10 years prior to enrollment that ruled out a progressive cause of epilepsy or an abnormality likely to be associated with focal-onset seizures.
  • Participant does not have a vagus nerve stimulator (VNS, LivaNova) or Participant’s VNS is OFF during the two month retrospective baseline and participant is willing to keep the VNS off during the study.


Exclusion Criteria:

  • Participant is pregnant.
  • Participant is participating in a therapeutic investigational drug or other device study.
  • Participant is implanted with an electronic medical device that delivers electrical energy to the brain.
  • Participant requires procedures that are contraindicated based on current RNS System labeling.
  • Participant has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Participants with post-ictal psychiatric symptoms need not be excluded.
  • In the opinion of the investigator, the participant has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease.
  • Participant has a history of partial-onset seizures or EEG findings within the past 2 years indicative of partial-onset or symptomatic generalized abnormalities.
  • Participant has been diagnosed with psychogenic or non-epileptic seizures in the preceding year.
  • Participant has experienced unprovoked status epilepticus in the preceding year.
  • Participant is taking any anticoagulants. Note: For contraindications, refer to current physician labeling (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/27/23. Questions regarding updates should be directed to the study team contact.

 

Device
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED) (VGN-TED-301)

A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Marius Stan
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2021-306514-P01-RST
21-012535
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis
associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale)
for the most severely affected eye (primary study eye) at Screening and Baseline

- Confirmed active TED (not sight-threatening but has an appreciable impact on daily
life, with onset (as determined by patient records) within 12 months prior to the
Baseline visit and usually associated with one or more of the following: lid
retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm
above normal for race and gender, and/or inconstant or constant diplopia.

- Subjects must be euthyroid with the participant's baseline disease under control or
have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free
triiodothyronine levels [FT3] < 50% above or below the normal limits) at Screening.

- Does not require immediate ophthalmic surgery, radiotherapy to orbits or other
ophthalmological intervention at the time of Screening and is not planning for any
such treatment during the course of the study.


Exclusion Criteria:


- Decreased best corrected visual acuity due to optic neuropathy as defined by a
decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color
defect secondary to optic nerve involvement within the last 6 months.

- Corneal decompensation unresponsive to medical management.

- Previous orbital irradiation or orbital surgery.

- Any glucocorticoid use (intravenous [IV] or oral) with a cumulative dose equivalent to
>= 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of
Screening.

- Prior IGF-1R inhibitor therapy for any condition.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/7/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Perceptions of Patients who Have Navigated Long-Haul COVID-19

Patients Perceptions of Long-Haul COVID-19

LuAnn Fowler
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308200-H01-RST
22-005063
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • ≥ 18 years of age and older.
  • Previous laboratory confirmed positive COVID-19 test.
  • Patient of the Public Health, Occupational Medicine, and Infectious Disease Clinic.
  • Patient of the Nurse Practitioner.


Exclusion Criteria:

  • Patients < 18 years of age.
  • Patients who are unable to return to work without restrictions and those who have not to return to work.
  • Patients who are not currently employed.

Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.

 

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)

All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04365374
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Patients aged 18 years old and above. Eligibility is restricted to this age group given that the battery of neurocognitive tests utilized in this protocol are not developed or validated for use in a younger population. 2. One to four newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor. 3. One lesion, designated the index lesion, is planned for surgical resection and is to be between 2.5 cm and 5.0 cm on the screening MRI. Index lesions > 2.0 cm but <2.5 cm are also eligible if surgery is deemed clinically necessary and appropriate for an attempted gross total resection by the neurosurgeon. 4. Non-index lesions must measure < 4.0 cm in maximal extent on the screening MRI brain scan. The unresected lesions will be treated with SRT as outlined in the treatment section of the concept. 5. All metastases must be located > 5 mm from the optic chiasm and outside the brainstem. Dural based metastasis are eligible. 6. Previous and/or concurrent treatment with systemic therapies (e.g., chemotherapy, targeted therapeutics, immunotherapy) is permitted and must follow protocol guidelines as follows: Systemic therapy is allowed a minimum of one week from last systemic therapy cycle to surgical resection, and one week after surgical resection to allow a minimum of one week before starting/resuming systemic therapy, depending on the specific systemic agent(s), as recommended by medical/neuro-oncology. Systemic therapy is not allowed 1 day before SRT, the same day as the SRT, or 1 day after the completion of the SRT or longer, depending on the specific systemic agent(s), as recommended by medical/neuro-oncology. Agents that are delivered by implant or depot injections (such as hormonal therapies) are excluded from these restrictions. 7. KPS score of ≥70. 8. Stable systemic disease or reasonable systemic treatment options predicting a life expectancy of ≥6 months. 9. Ability to complete an MRI of the head with contrast 10. Adequate renal and hepatic function to undergo surgery, in investigators opinion. 11. For women of childbearing potential only, a negative urine or serum pregnancy test done < 7 days prior to randomization is required. Women must be willing to notify investigator immediately if they become pregnant at any time during the trial period. 12. Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment. 13. Subjects must be fluent in English or Spanish language. English speaking subjects will complete Neurocognitive assessments. Non-English speaking subjects will not complete the Neurocognitive assessments as the psychometric properties for translated tests are either not known or not as robust. 14. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves. Exclusion Criteria 1. Age <18 years. 2. KPS<70 3. Past radiation or surgical therapy to the index lesion or the newly diagnosed non-index lesion(s) is exclusionary. However, up to a total of 2 prior courses of SRT treatment to previously diagnosed lesions are allowed as long as any treated lesions are were >15mm from the index lesion. 4. Patients with >4 newly diagnosed metastases on screening MRI 5. Pregnant patients. 6. Primary germ cell tumor, small cell carcinoma, or lymphoma. 7. Leptomeningeal metastasis (LMD). Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as radiologic or clinical evidence of leptomeningeal involvement with or without positive cerebrospinal fluid (CSF) cytology. 8. Prior WBRT for brain metastases. 9. Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device. 10. Comorbid psychiatric or neurologic disease or injury impacting cognition, in the opinion of the treating physician, that might impair patient's ability to understand or comply with the requirements of the study or to provide consent 11. Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care.
Device: Gamma Tile-Surgically Targeted Radiation Therapy (STaRT), Radiation: Stereotactic Radiation Therapy
Brain Metastases
Brain, Tumor, Cancer, New Diagnosis, Metastases, GammaTile, Radiation, Cs-131
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 2 locations
Hide all locations

Location Contacts
Abbott Northwestern Hospital — Minneapolis, Minnesota Jennifer Murwin - (jennifer.murwin@allina.com)
University of Minnesota — Minneapolis, Minnesota Clark Chen, MD

A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa

All
18 Years to 99 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05453578
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Subjects must meet all the inclusion criteria to be eligible to participate in the study: 1. Adult (>/= 18 years) at the time of screening. 2. Confirmed CF diagnosis based on a compatible clinical syndrome confirmed by either an abnormal sweat chloride testing or CFTR gene variations.* *Can be obtained from documentation in medical records; actual test results not necessary. 3. Likely able to produce at least 2 mL of sputum during a 30-minute sputum collection following a hypertonic saline treatment or other approach to increase sputum production.* **Determined by investigator or their designee judgement. Approaches for obtaining sputum may include, but are not limited to, inhaled hypertonic saline (e.g. 3%, 7%, or 10%), inhaled hypertonic bicarbonate, inhaled mannitol, or spontaneously expectorated sputum. The same approach is recommended, whenever possible, for all sputum collections for a given subject. 4. P. aeruginosa (regardless of Colony Forming Units (CFU)/mL) isolated from a sputum, throat culture, or other respiratory specimen in the past 12 months. 5. Confirmed P. aeruginosa isolation from a sample of expectorated sputum at the Screening Visit. 6. Capable of providing informed consent. 7. Capable and willing to complete all study visits and perform all procedures required by the protocol.
Exclusion Criteria:
Subjects who meet any of the exclusion criteria will not be enrolled in the study: 1. Body weight < 30 kg. 2. Forced Expiratory Volume 1 second < 20% of predicted value at screening, using the Hankinson equations. 3. Elevated LFTs obtained at screening.* *a. Alanine aminotransferase (ALT) > 5 x the upper limit of normal (ULN) or aspartate transaminase (AST) > 5 x ULN or total bilirubin > 3 x ULN, OR b. Total bilirubin > 1.5 x ULN combined with either ALT > 3 x ULN or AST > 3 x ULN. ULN reflects local laboratory ranges. 4. Acute clinical illness requiring a new (oral, parenteral), or inhaled antibiotic(s) 45 years old and has gone at least 12 months without a spontaneous menstrual period without other known or suspected cause. 3. Effective methods of contraception include (a) abstinence, (b) partner vasectomy, (c) intrauterine devices, (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings). 6. Active treatment of any mycobacterial or fungal organisms
Other: Placebo, Biological: WRAIR-PAM-CF1
Bacterial Disease Carrier, Cystic Fibrosis
Bacteriophage therapy, Cystic Fibrosis, Microbiological Activity, Pseudomonas aeruginosa, Safety
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Hide all locations

Location Contacts
University of Minnesota Medical Center — Minneapolis, Minnesota

The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study

All
up to 22 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04726241
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Patients must be less than 22 years of age at the time of study enrollment
• Patient must have one of the following:
• Patient has known or suspected relapsed/refractory (including primary refractory) AML
• This includes isolated myeloid sarcoma
• Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome
• Patient has known or suspected relapsed ALL that meets one of the following criteria:
• Second or greater B-ALL medullary relapse, excluding KMT2Ar.
• Any first or greater B-ALL medullary relapse involving KMT2Ar.
• Any first or greater T-ALL medullary relapse with or without KMT2Ar.
• Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL)
• Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML) or treatment-related myelodysplastic syndrome (t-MDS)
• Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS)
• Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Procedure: Biospecimen Collection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome Post Cytotoxic Therapy, Myeloid Leukemia Associated With Down Syndrome
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 2 locations
Hide all locations

Location Contacts
Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota Site Public Contact

The Effects of Glucagon on Hepatic Metabolism

The Effects of Glucagon on Hepatic Metabolism

Adrian Vella
All
25 years to 65 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-306820-H01-RST
22-000113
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Willing to participate.
- Able to give consent.


Exclusion Criteria:


- History of prior upper abdominal surgery; e.g., gastric banding, pyloroplasty, vagotomy.
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
- Contraindications to MRI (e.g., metal implants, claustrophobia).
- Hematocrit < 35%.
- TSH < 0.4 or > 5.5.
- Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/6/23. Questions regarding updates should be directed to the study team contact.

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05671380
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• English or Spanish-speaking BIPOC patients within the Hennepin Healthcare or MCHS system. BIPOC patients are any patients with a chart identified race that is not White, and will be verified by self-report from the baseline survey.
• Currently smoke >1 cigarette over the past 30 days
• Must have address or telephone number in the electronic health record
Exclusion Criteria:

• Electronic health record documented cognitive impairment or legal guardianship
• Patients who have opted out of reserach studies
Behavioral: Longitudinal Proactive Outreach (LPO)., Behavioral: Ask-Advice-Connect (AAC)
Tobacco Use Cessation, Cardiovascular Diseases, Tobacco Use, Smoking, Smoking Cessation
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 2 locations
Hide all locations

Location Contacts
Hennepin Healthcare — Minneapolis, Minnesota
University of Minnesota — Minneapolis, Minnesota

Blinded Reference Set for Multicancer Early Detection Blood Tests

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Amrit Singh
All
40 years to 75 years old
This study is NOT accepting healthy volunteers
2021-305158-P01-MAIJ
22-011457
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Participants with a cancer diagnosis: Documentation of disease:

- Histologic documentation: Histologically confirmed diagnosis of invasive cancer;

- Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with
the exception of patients with leukemia, lymphoma, and multiple myeloma;

- For leukemia: Type (chronic lymphocytic leukemia [CLL], chronic myeloid
leukemia [CML], acute lymphoblastic lymphoma [ALL], acute myeloid leukemia
[AML]);

- For lymphoma: Stage I-IV based on Ann Arbor staging;

- For multiple myeloma: Stage I, II, III based on Revised International
Staging System (RISS).

- One of the following tumor types:

- Colorectal;

- Bladder;

- Head and neck;

- Hepatobiliary;

- Lung;

- Lymphoma;

- Leukemia;

- Ovary *** For these specific cancer types only, patients may be enrolled
prior to histologic confirmation of malignancy. Sites are required to
contact the study chairs to review appropriateness for enrollment;

- Pancreas *** For these specific cancer types only, patients may be enrolled
prior to histologic confirmation of malignancy. Sites are required to
contact the study chairs to review appropriateness for enrollment;

- Multiple myeloma;

- Gastric, esophageal or gastroesophageal;

- Breast;

- Thyroid;

- Kidney;

- For these specific cancer types only, patients may be enrolled prior to
histologic confirmation of malignancy. Sites are required to contact
the study chairs to review appropriateness for enrollment;

- Endometrium;

- Prostate;

- Melanoma;

*** For these specific cancer types only, patients may be enrolled prior to
histologic confirmation of malignancy. Sites are required to contact the
study chairs to review appropriateness for enrollment;

- Sarcoma.

- Participants with a cancer diagnosis: No prior definitive systemic or local
anti-cancer intervention.

- Participants with a cancer diagnosis: Age ≥ 40 and ≤ 75.

- Participants with a cancer diagnosis: No known current pregnancy by self-report.

- Participants with a cancer diagnosis: No known or prior history of in situ or invasive
malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer
diagnosis.

- Participants with a cancer diagnosis: Willingness to provide blood samples for
research use.

- Participants with a cancer diagnosis: Absence of medical contraindications to a
research blood draw volume of 60 mL.

- Participants with a cancer diagnosis: No history of organ transplantation.

- Participants with a cancer diagnosis: Ability to read and comprehend English or
Spanish.

* Eligibility is restricted to individuals who can comprehend and read English or
Spanish given that participation in the study will require the ability to read and
complete questionnaires that are available only in those two languages.

- Participants without a cancer diagnosis and without suspicion of cancer: Age ≥ 40 and
≤ 75.

- Participants without a cancer diagnosis and without suspicion of cancer: No known
current pregnancy by self-report.

- Participants without a cancer diagnosis and without suspicion of cancer: No known or
prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin
cancers).

- Participants without a cancer diagnosis and without suspicion of cancer: Willingness
to provide blood samples for research use.

- Participants without a cancer diagnosis and without suspicion of cancer: Absence of
medical contraindications to a research blood draw volume of 60 mL.

- Participants without a cancer diagnosis and without suspicion of cancer: No history of
organ transplantation.

- Participants without a cancer diagnosis and without suspicion of cancer: Ability to
read and comprehend English or Spanish.

* Eligibility is restricted to individuals who can comprehend and read English or
Spanish given that participation in the study will require the ability to read and
complete questionnaires that are available only in those two languages.

- Participants with a high suspicion of cancer: High suspicion of ovarian cancer,
pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological
assessment, with plans for histologic or cytologic confirmation within 28 days after
study blood draw.

* Examples of highly suspicious cases include: elevated CA125 and abnormal
transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious
cutaneous lesion concerning for melanoma.

- Participants with a high suspicion of cancer: Central review of radiology reports
and/or clinical documentation conducted by study chairs.

- Participants with a high suspicion of cancer: Age ≥ 40 and ≤ 75.

- Participants with a high suspicion of cancer: No known current pregnancy by
self-report.

- Participants with a high suspicion of cancer: No known or prior history of in situ or
invasive malignancy (excluding in situ non-melanoma skin cancers) other than the
current cancer diagnosis.

- Participants with a high suspicion of cancer: Willingness to provide blood samples for
research use.

- Participants with a high suspicion of cancer: Absence of medical contraindications to
a research blood draw volume of 60 mL.

- Participants with a high suspicion of cancer: No history or organ transplantation.

- Participants with a high suspicion of cancer: Ability to read and comprehend English
or Spanish *.   Eligibility is restricted to individuals who can comprehend and read
English and Spanish given that participation in the study will require the ability to
read and complete questionnaires that are available only in those two languages.

Eligibility last updated 10/27/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Mankato, MN

Blinded Reference Set for Multicancer Early Detection Blood Tests

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Mina Hanna
All
40 years to 75 years old
This study is NOT accepting healthy volunteers
2021-305158-P01-ALCL
22-011457
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Participants with a cancer diagnosis: Documentation of disease:

- Histologic documentation: Histologically confirmed diagnosis of invasive cancer;

- Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with
the exception of patients with leukemia, lymphoma, and multiple myeloma;

- For leukemia: Type (chronic lymphocytic leukemia [CLL], chronic myeloid
leukemia [CML], acute lymphoblastic lymphoma [ALL], acute myeloid leukemia
[AML]);

- For lymphoma: Stage I-IV based on Ann Arbor staging;

- For multiple myeloma: Stage I, II, III based on Revised International
Staging System (RISS).

- One of the following tumor types:

- Colorectal;

- Bladder;

- Head and neck;

- Hepatobiliary;

- Lung;

- Lymphoma;

- Leukemia;

- Ovary *** For these specific cancer types only, patients may be enrolled
prior to histologic confirmation of malignancy. Sites are required to
contact the study chairs to review appropriateness for enrollment;

- Pancreas *** For these specific cancer types only, patients may be enrolled
prior to histologic confirmation of malignancy. Sites are required to
contact the study chairs to review appropriateness for enrollment;

- Multiple myeloma;

- Gastric, esophageal or gastroesophageal;

- Breast;

- Thyroid;

- Kidney;

- For these specific cancer types only, patients may be enrolled prior to
histologic confirmation of malignancy. Sites are required to contact
the study chairs to review appropriateness for enrollment;

- Endometrium;

- Prostate;

- Melanoma;

*** For these specific cancer types only, patients may be enrolled prior to
histologic confirmation of malignancy. Sites are required to contact the
study chairs to review appropriateness for enrollment;

- Sarcoma.

- Participants with a cancer diagnosis: No prior definitive systemic or local
anti-cancer intervention.

- Participants with a cancer diagnosis: Age ≥ 40 and ≤ 75.

- Participants with a cancer diagnosis: No known current pregnancy by self-report.

- Participants with a cancer diagnosis: No known or prior history of in situ or invasive
malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer
diagnosis.

- Participants with a cancer diagnosis: Willingness to provide blood samples for
research use.

- Participants with a cancer diagnosis: Absence of medical contraindications to a
research blood draw volume of 60 mL.

- Participants with a cancer diagnosis: No history of organ transplantation.

- Participants with a cancer diagnosis: Ability to read and comprehend English or
Spanish.

* Eligibility is restricted to individuals who can comprehend and read English or
Spanish given that participation in the study will require the ability to read and
complete questionnaires that are available only in those two languages.

- Participants without a cancer diagnosis and without suspicion of cancer: Age ≥ 40 and
≤ 75.

- Participants without a cancer diagnosis and without suspicion of cancer: No known
current pregnancy by self-report.

- Participants without a cancer diagnosis and without suspicion of cancer: No known or
prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin
cancers).

- Participants without a cancer diagnosis and without suspicion of cancer: Willingness
to provide blood samples for research use.

- Participants without a cancer diagnosis and without suspicion of cancer: Absence of
medical contraindications to a research blood draw volume of 60 mL.

- Participants without a cancer diagnosis and without suspicion of cancer: No history of
organ transplantation.

- Participants without a cancer diagnosis and without suspicion of cancer: Ability to
read and comprehend English or Spanish.

* Eligibility is restricted to individuals who can comprehend and read English or
Spanish given that participation in the study will require the ability to read and
complete questionnaires that are available only in those two languages.

- Participants with a high suspicion of cancer: High suspicion of ovarian cancer,
pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological
assessment, with plans for histologic or cytologic confirmation within 28 days after
study blood draw.

* Examples of highly suspicious cases include: elevated CA125 and abnormal
transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious
cutaneous lesion concerning for melanoma.

- Participants with a high suspicion of cancer: Central review of radiology reports
and/or clinical documentation conducted by study chairs.

- Participants with a high suspicion of cancer: Age ≥ 40 and ≤ 75.

- Participants with a high suspicion of cancer: No known current pregnancy by
self-report.

- Participants with a high suspicion of cancer: No known or prior history of in situ or
invasive malignancy (excluding in situ non-melanoma skin cancers) other than the
current cancer diagnosis.

- Participants with a high suspicion of cancer: Willingness to provide blood samples for
research use.

- Participants with a high suspicion of cancer: Absence of medical contraindications to
a research blood draw volume of 60 mL.

- Participants with a high suspicion of cancer: No history or organ transplantation.

- Participants with a high suspicion of cancer: Ability to read and comprehend English
or Spanish *.   Eligibility is restricted to individuals who can comprehend and read
English and Spanish given that participation in the study will require the ability to
read and complete questionnaires that are available only in those two languages.

Eligibility last updated 10/27/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Albert Lea, MN

CAAA617C12301, PSMAddition: An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (PSMAddition)

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC

Brian Costello
Male
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306540-P01-RST
22-000515
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


Participants eligible for inclusion in this study must meet all of the following criteria:

1. Signed informed consent must be obtained prior to participation in the study

2. Patients must be adults ≥18 years of age

3. Patients must have an ECOG performance status of 0 to 2

4. Patients must have a life expectancy >9 months as determined by the study investigator

5. Patients must have metastatic prostate cancer with histologically or cytologically
confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic
site)

6. Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT
scan, and eligible as determined by the sponsor's central reader

7. Patients must have at least one documented metastatic bone and/or soft tissue/visceral
lesion documented in the following manners within 28 days prior randomization:

1. Metastatic disease to the bone (in any distribution) visible on 99Tc-MDP bone
scintigraphy on either pre-ADT scans or baseline scans AND/OR

2. Lymph node metastases of any size or distribution. If lymph nodes are the only
site of metastasis, then at least one must be at least 1.5 cm in short axis AND
outside of the pelvis AND/OR

3. Visceral metastases of any size or distribution. If a participant has a history
of visceral metastases at any time prior to randomization, he should be coded as
having visceral metastases at baseline (i.e., patients with visceral metastases
prior to ADT that disappear at baseline will be counted as having visceral
metastases and would therefore have high volume disease for stratification
purposes).

8. Patients must have adequate organ function:

- Bone marrow reserve ANC ≥1.5 x 109/L Platelets ≥100 x 109/L Hemoglobin ≥9 g/dL

- Hepatic Total bilirubin ≤2 x the institutional upper limit of normal (ULN). For
patients with known Gilbert's Syndrome ≤3 x ULN is permitted Alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x
ULN for patients with liver metastases

- Renal eGFR ≥ 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease
(MDRD) equation

9. Albumin ≥2.5 g/dL

10. Human immunodeficiency virus (HIV)-infected patients who are healthy and have a low
risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in
this trial

11. Patients must be:

Treatment naïve OR minimally treated with:

- Up to 45 days of luteinizing hormone-releasing hormone (LHRH) agonist /antagonists or
bilateral orchiectomy with or without first generation anti-androgen (e.g.
bicalutamide, flutamide) for metastatic prostate cancer is allowed prior to ICF
signature. If given, first generation anti-androgen must be discontinued prior to
start of study therapy or after 45 days whatever happens first.

- If received, prior LHRH agonist/antagonist with or without first generation
anti-androgen use in the adjuvant/neo-adjuvant setting must have been discontinued >
12 months prior to ICF signature AND must not have exceeded 24 months of therapy AND
must not have shown disease progression within 12 months of completing
adjuvant/neo-adjuvant therapy.

- Up to 45 days of CYP17 inhibitor or ARDT exposure for metastatic prostate cancer is
allowed prior to ICF signature. No CYP17 inhibitor or ARDT exposure for earlier stages
of prostate cancer is allowed.


Exclusion Criteria:


Participants meeting any of the following criteria are not eligible for inclusion in this
study.

1. Participants with rapidly progressing tumor that requires urgent exposure to
taxane-based chemotherapy

2. Any prior systemic anti-prostate cancer therapy (with the exception of the drugs
listed on inclusion criteria 11), including chemotherapy, Poly (adenosine
diphosphate-ribose) polymerase (PARP) inhibitors, immunotherapy or biological therapy
(including monoclonal antibodies).

3. Concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, PARP
inhibitor, biological therapy or investigational therapy

4. Previous treatment with any of the following within 6 months of randomization:
Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body
irradiation. Previous PSMA-targeted radioligand therapy is not allowed

5. Ongoing participation in any other clinical trial

6. Use of other investigational drugs within 30 days prior to day of randomization

7. Known hypersensitivity to any of the study treatments or its excipients or to drugs of
similar chemical classes

8. Transfusion for the sole purpose of making a participant eligible for study inclusion

9. Participants with CNS metastases that are neurologically unstable, symptomatic, or
receiving corticosteroids for the purpose of maintaining neurologic integrity.
Participants with epidural disease, canal disease and prior cord involvement are
allowed if those areas have been treated, are stable, and not neurologically impaired.
Participants with parenchymal CNS metastasis (or a history of CNS metastasis), that
have received prior therapy and are neurologically stable, asymptomatic and not
receiving steroids for CNS metastases, are allowed, baseline and subsequent
radiological imaging must include evaluation of the brain (magnetic resonance imaging
(MRI) preferred or CT with contrast).

10. Diagnosed with other malignancies that are expected to alter life expectancy or may
interfere with disease assessment. However, participants with a prior history of
malignancy that has been adequately treated and who have been disease free, treatment
free for more than 3 years prior to randomization, or participants with adequately
treated non-melanoma skin cancer, superficial bladder cancer are eligible.

11. Concurrent serious (as determined by the Principal Investigator) medical conditions,
including, but not limited to, uncontrolled infection, known active hepatitis B or C,
or other significant co-morbid conditions that in the opinion of the investigator
would impair study participation or cooperation. Participants with an active
documented COVID-19 infection (any grade of disease severity) at time of informed
consent may be included only when completely recovered (in accordance with local
guidance).

12. Active clinically significant cardiac disease defined as any of the following:

- NYHA class 3/4 congestive heart failure within 6 months prior to ICF signature
unless treated with improvement and echocardiogram or MUGA demonstrates EF > 45%
with improvement in symptoms to class < 3.

- History or current diagnosis of ECG abnormalities indicating significant risk of
safety for participants in the study such as: Concomitant clinically significant
cardiac arrhythmias, e.g. sustained ventricular tachycardia, complete left bundle
branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block,
Mobitz type II and third degree AV block)

- History of familial long QT syndrome or known family history of Torsades de
Pointes

- Cardiac or cardiac repolarization abnormality, including any of the following:
History of myocardial infarction (MI), angina pectoris, or coronary artery bypass
graft (CABG) within 6 months prior to ICF signature

13. History of somatic or psychiatric disease/condition that may interfere with the
objectives and assessments of the study

14. Symptomatic cord compression, or clinical or radiologic findings indicative of
impending cord compression

15. Any condition that precludes raised arms position

16. Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note:
participants with bladder outflow obstruction or urinary incontinence, which is
manageable and controlled with best available standard of care (incl. pads, drainage)
are allowed.

17. Sexually active males unwilling to use a condom during intercourse while taking study
treatment and for 14 weeks after stopping study treatment. A condom is required for
all sexually active male participants to prevent them from fathering a child AND to
prevent delivery of study treatment via seminal fluid to their partner. In addition,
male participants must not donate sperm for the time period specified above. If local
regulations deviate from the contraception methods listed above to prevent pregnancy,
local regulations apply and will be described in the ICF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/28/23. Questions regarding updates should be directed to the study team contact.

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Mobile Food Market Cluster Randomized Trial

All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT05672186
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Community sites (e.g., public housing hi-rise, low-income senior living residence) must meet the following criteria:
• locale for low-income populations that experience difficulty in accessing healthy, affordable foods (e.g., public housing residences; low-income senior housing) or a community center in a low-income, low-food access (0.5 mile) census tract;
• willingness to be randomized to the intervention or waitlist control;
• located over 0.5 miles apart from other trial sites;
• willingness to allow for recruitment and data collection to occur in onsite community rooms Participants must meet the following criteria:
• being aged 18 years or older;
• identifying as the primary food shopper in their household;
• being able to speak English or ASL;
• living within a half mile of the community site location; and
• reporting to be likely or somewhat likely to shop at the market in response to: "how likely would you be to shop regularly at the Twin Cities Mobile Market if it came to your neighborhood each week (response options: likely to unlikely).
• willing and able to participate in all study data collection activities
Exclusion Criteria:

• planning to move in the next 12 months
• currently shopping at the mobile market
• not having a phone number or mailing address
• presence of a condition or abnormality that would prohibit participation in the study or the quality of the data
Behavioral: Full-service market intervention, Other: No intervention
Healthy Diet, Nutrition, Healthy
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Hide all locations

Location Contacts
University of Minnesota — Minneapolis, Minnesota Melissa Horning - (horn0199@umn.edu)

A Multidisciplinary Translational Approach to Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache

A Study to Investigate Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache

Dmitry Esterov
All
18 years to 70 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122010-H01-RST
19-003200
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as
defined by the International Classification of Headache Disorders (ICHD-3).

- PTH onset 7-28 days prior to the time of enrollment

- Adults 18-70 years of age

- Willing to be randomized to either of the two clinical trial treatment arms

- Willing to maintain a headache diary

- Willing and able to return for follow-up visits

- 5 or more moderate or severe headache days during the 4-week run-in phase

- At least 80% compliant with diary keeping during the 4-week run-in phase (i.e.,
provides data on at least 80% of days)


Exclusion Criteria:


- Episodic tension-type headache, migraine, or other headaches with at least 4 headache
days/month on average over the 6 months prior to the mTBI resulting in PTH

- Previous history of chronic headache (i.e., at least 15 headache days/month) including
PPTH, chronic migraine, medication overuse headache, new daily persistent headache,
hemicrania continua, chronic tension-type headache

- Diminished decision-making capacity that in the investigator's opinion would interfere
with the person's ability to provide informed consent and complete study procedures

- Current or prior use of preventive medications for migraine or other primary headache
disorder

- Use of onabotulinumtoxinA in the head, neck or face region within 12 months of
screening

- During the 6 months before screening, use of opioids or barbiturates on an average of
at least 4 days per month

- Subjects who underwent an intervention or used a device (e.g., nerve blocks,
transcranial magnetic stimulation, vagal nerve stimulation, or electrical trigeminal
nerve stimulation) for headache

- History of major psychiatric disorder such as schizophrenia and bipolar disorder

- History or evidence of any unstable or clinically significant medical condition, that
in the opinion of the investigator, would pose a risk to subject safety or interfere
with the study evaluation, procedures, or completion

- History of positive neuroimaging findings that indicate a moderate or severe TBI

- Contraindications to magnetic resonance imaging, including, but not limited to (only
an exclusion for patients participating in the brain MRI portion of this research):

1. Metal implants

2. Aneurysm clips

3. Severe claustrophobia

4. Implanted electronic device

5. Insulin or infusion pump

6. Cochlear/otologic/ear implant

7. Non-removable prosthesis

8. Implanted shunts/catheters

9. Certain intrauterine devices

10. Tattooed makeup

11. Body piercings that cannot be removed

12. Metal fragments

13. Wire sutures or metal staples

- Factors that reduce MR image quality and interpretability (only an exclusion for
patients participating in the brain MRI portion of this research):

1. Dental braces or other non-removable devices (e.g., retainers)

2. Prior brain surgery

3. Known brain MRI abnormality that in the investigator's opinion will significantly
impact MRI data

- Sensory disorders that in the investigator's opinion might affect perception of
cutaneous thermal stimuli (e.g., peripheral neuropathy) (only an exclusion for
patients participating in the neurophysiology studies)

- Pregnancy

- Breastfeeding

- History of myocardial infarction, stroke, transient ischemic attack, unstable angina,
coronary artery bypass surgery, or other revascularization procedures within 12 months
prior to screening.

- Not willing to use a reliable form of contraception (for women of childbearing
potential) through 16 weeks after the last dose of erenumab. Acceptable methods of
birth control include not having intercourse, hormonal birth control methods,
intrauterine devices, surgical contraceptive methods, or two barrier methods (each
partner must use a barrier method) with spermicide. A reliable form of contraception
must be started prior to or at the time of starting the run-in phase. Not being of
childbearing potential is defined as any woman who is post-menopausal by history,
defined as:

1. At least 55 years of age with cessation of menses for 12 or more months; OR

2. Younger than 55 years of age but no spontaneous menses for at least 2 years; OR

3. Younger than 55 years of age and spontaneous menses within the past 1 year, but
currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND with
postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating
hormone levels at least 40 IU/L) or postmenopausal estradiol level (less than 5
ng/dL) or according to the definition of "postmenopausal range" for the
laboratory involved; OR

4. Underwent bilateral oophorectomy; OR

5. Underwent hysterectomy; OR

6. Underwent bilateral salpingectomy.

- Currently or within 90 days prior to screening: received treatment in another drug
study or an investigational device study

- Has previously received any CGRP ligand or receptor targeted monoclonal antibody

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/25/22. Questions regarding updates should be directed to the study team contact.

Other
Chronic daily headache, Concussion, Head and brain injury, Head injury, Headache NOS, Traumatic brain injury, Traumatic injury
Chronic post-traumatic headache, Concussion injury of brain, Nervous system
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Multidisciplinary Translational Approach to Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache - Human Studies Protocol: Individual Projects Excluding Clinical Trial

Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache

Dmitry Esterov
All
18 years to 70 years old
Not Applicable
This study is NOT accepting healthy volunteers
2020-300125-H01-RST
20-003732
Show full eligibility criteria
Hide eligibility criteria

PATH A (all studies NOT including the clinical trial)

Inclusion Criteria:

  • Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as defined by the International Classification of Headache Disorders (ICHD-3).
  • PTH onset 7-28 days prior to the time of enrollment.
  • Adults,18-70 years of age.
  • Willing to be randomized to either of the two clinical trial treatment arms.
  • Willing to maintain a headache diary.
  • Willing and able to return for follow-up visits.
  • Additional Inclusion Criteria for Randomization into the Clinical Trial (assessed after run-in phase).
  • 5 or more moderate or severe headache days during the 4-week run-in phase.
  • At least 80% compliant with diary keeping during the 4-week run-in phase (i.e., provides data on at least 80% of days).


Exclusion Criteria:

  • Episodic tension-type headache, migraine, or other headaches with at least 4 headache days/month on average over the 6 months prior to the mTBI resulting in PTH.
  • Previous history of chronic headache (i.e., at least 15 headache days/month) including PPTH, chronic migraine, medication overuse headache, new daily persistent headache, hemicrania continua, chronic tension-type headache.
  • Diminished decision-making capacity that in the investigator’s opinion would interfere with the person’s ability to provide informed consent and complete study procedures.
  • Current or prior use of preventive medications for migraine or other primary headache disorder.
  • Use of onabotulinumtoxinA in the head, neck or face region within 12 months of screening.
  • During the 6 months before screening, use of opioids or barbiturates on an average of at least 4 days per month.
  • Subjects who underwent an intervention or used a device (e.g., nerve blocks, transcranial magnetic stimulation, vagal nerve stimulation, or electrical trigeminal nerve stimulation) for headache.
  • History of major psychiatric disorder such as schizophrenia and bipolar disorder.
  • History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
  • History of positive neuroimaging findings that indicate a moderate or severe TBI.
  • Sensory disorders that in the investigator’s opinion might affect perception of cutaneous thermal stimuli (e.g., peripheral neuropathy).
  • Pregnancy.
  • Breastfeeding.
  • History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening.
  • Not willing to use a reliable form of contraception (for women of childbearing potential) through 16 weeks after the last dose of erenumab. Acceptable methods of birth control include not having intercourse, hormonal birth control methods, intrauterine devices, surgical contraceptive methods, or two barrier methods (each partner must use a barrier method) with spermicide. A reliable form of contraception must be started prior to or at the time of starting the run-in phase. Not being of childbearing potential is defined as any woman who:
    • Is post-menopausal by history, defined as:
      • At least 55 years of age with cessation of menses for 12 or more months, OR
      • Younger than 55 years of age but no spontaneous menses for at least 2 years, OR
      • Younger than 55 years of age and spontaneous menses within the past 1 year, but currently amenorrheic (e.g. spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels at least 40 IU/L) or postmenopausal estradiol level (less than 5 ng/dL) or according to the definition of “postmenopausal range” for the laboratory involved; OR
      • Underwent bilateral oophorectomy; OR
      • Underwent hysterectomy; OR
      • Underwent bilateral salpingectomy.
  • Currently or within 90 days prior to screening: received treatment in another drug study or an investigational device study.
  • Has previously received any CGRP ligand or receptor targeted monoclonal antibody.

PATH B (all studies except for the clinical trial)

Inclusion Criteria:

  • Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as defined by the International Classification of Headache Disorders (ICHD-3).
  • PTH onset 7-28 days prior to the time of enrollment.
  • Adults 18-70 years of age.
  • Willing to maintain a headache diary.
  • Willing and able to return for follow-up visits.


Exclusion Criteria:

  • Episodic tension-type headache, migraine, or other headaches with at least 4 headache days/month on average over the 6 months prior to the mTBI resulting in PTH.
  • Previous history of chronic headache (i.e. at least 15 headache days/month) including PPTH, chronic migraine, medication overuse headache, new daily persistent headache, hemicrania continua, chronic tension-type headache.
  • Diminished decision-making capacity that in the investigator’s opinion would interfere with the person’s ability to provide informed consent and complete study procedures.
  • Current or prior use of preventive medications for migraine or other primary headache disorder.
  • Use of onabotulinumtoxinA in the head, neck or face region within 12 months of screening.
  • During the 6 months before screening, use of opioids or barbiturates on at least 4 days per month.
  • Subjects who underwent an intervention or used a device (e.g., nerve blocks, transcranial magnetic stimulation, vagal nerve stimulation, or electrical trigeminal nerve stimulation) for headache.
  • History of major psychiatric disorder such as schizophrenia and bipolar disorder.
  • History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
  • History of positive neuroimaging findings that indicate a moderate or severe TBI.
  • Sensory disorders that in the investigator’s opinion might affect perception of cutaneous thermal stimuli (e.g., peripheral neuropathy).
  • Pregnancy.
  • Breastfeeding.
  • Currently or within 90 days prior to screening: received treatment in another drug study or an investigational device study.

PATH C (phenotyping, molecular/genetic biomarker, clinical trial)

Inclusion Criteria:

  • Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as defined by the International Classification of Headache Disorders (ICHD-3).
  • PTH onset 7-28 days prior to the time of enrollment.
  • Adults, 18-70 years of age.
  • Willing to be randomized to either of the two clinical trial treatment arms.
  • Willing to maintain a headache diary.
  • Willing and able to return for follow-up visits.


Exclusion Criteria:

  • Episodic tension-type headache, migraine, or other headaches with at least 4 headache days/month on average over the 6 months prior to the mTBI resulting in PTH.
  • Previous history of chronic headache (i.e. at least 15 headache days/month) including PPTH, chronic migraine, medication overuse headache, new daily persistent headache, hemicrania continua, chronic tension-type headache.
  • Diminished decision-making capacity that in the investigator’s opinion would interfere with the person’s ability to provide informed consent and complete study procedures.
  • Current or prior use of preventive medications for migraine or other primary headache disorder.
  • Use of onabotulinumtoxinA in the head, neck or face region within 12 months of screening.
  • During the 6 months before screening, use of opioids or barbiturates on average at least 4 days per month.
  • Subjects who underwent an intervention or used a device (e.g., nerve blocks, transcranial magnetic stimulation, vagal nerve stimulation, or electrical trigeminal nerve stimulation) for headache.
  • History of major psychiatric disorder such as schizophrenia and bipolar disorder.
  • History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
  • Pregnancy.
  • Breastfeeding.
  • History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening.
  • Not willing to use a reliable form of contraception (for women of childbearing potential) through 16 weeks after the last dose of erenumab. Acceptable methods of birth control include not having intercourse, hormonal birth control methods, intrauterine devices, surgical contraceptive methods, or two barrier methods (each partner must use a barrier method) with spermicide. A reliable form of contraception must be started prior to or at the time of starting the run-in phase. Not being of childbearing potential is defined as any woman who:
    • Is post-menopausal by history, defined as:
      • At least 55 years of age with cessation of menses for 12 or more months; OR
      • Younger than 55 years of age but no spontaneous menses for at least 2 years; OR
      • Younger than 55 years of age and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels at least 40 IU/L) or postmenopausal estradiol level (less than 5 ng/dL) or according to the definition of “postmenopausal range” for the laboratory involved; OR
      • Underwent bilateral oophorectomy; OR
      • Underwent hysterectomy; OR
      • Underwent bilateral salpingectomy.
  • Currently or within 90 days prior to screening: received treatment in another drug study or an investigational device study.
  • Has previously received any CGRP ligand or receptor targeted monoclonal antibody.

PATIENT ELIGIBILITY FOR HEALTHY CONTROLS

Inclusion Criteria:

  • Adults, 18-70 years of age.
  • Willing and able to return for follow-up visits.


Exclusion Criteria:

  • History of traumatic brain injury.
  • History of migraine or other headaches:
    • Tension-type headache up to an average of 3 days per month is allowed.
  • Diminished decision-making capacity that in the investigator’s opinion would interfere with the person’s ability to provide informed consent and complete study procedures
  • During the 6 months before screening, use of opioids or barbiturates on an average of at least 4 days per month
  • History of major psychiatric disorder such as schizophrenia and bipolar disorder
  • History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
  • Sensory disorders that in the investigator’s opinion might affect perception of cutaneous thermal stimuli (e.g. peripheral neuropathy).
  • Pregnancy.
  • Breastfeeding.
  • Currently or within 90 days prior to screening: received treatment in another drug study or an investigational device study.
  • Has previously received any CGRP ligand or receptor targeted monoclonal antibody.

Exclusion Criteria
•PART A, PART B and HEALTHY CONTROLS

  • Contraindications to magnetic resonance imaging, including, but not limited to:
    • Metal implants;
    • Aneurysm clips;
    • Severe claustrophobia;
    • Implanted electronic devices;
    • Insulin or infusion pump;
    • Cochlear/otologic/ear implant;
    • Non-removable prosthesis;
    • Implanted shunts/catheters;
    • Certain intrauterine devices;
    • Tattooed makeup;
    • Body piercings that cannot be removed;
    • Metal fragments;
    • Wire sutures or metal staples.
  • Factors that reduce MR image quality and interpretability:
    • Dental braces or other non-removable devices (e.g., retainers);
    • Prior brain surgery;
    • Known brain MRI abnormality that in the investigator’s opinion will significantly impact MRI data.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/30/22. Questions regarding updates should be directed to the study team contact.

Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia

Tradipitant for Functional Dyspepsia

Xiao Jing Wang
All
18 years to 70 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306560-H01-RST
21-012527
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Able to provide written consent

- Body Mass Index (BMI) of 18-35 kg/m2

- Absence of other diseases which could interfere with interpretation of study results


Exclusion Criteria:


- Current H. pylori infection

- Pregnancy or nursing

- Recent history of Alcohol Use Disorder or Substance Use Disorder

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/21/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis: A Community Study

Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis

Omar Abou Ezzeddine
All
75 years and over
This study is NOT accepting healthy volunteers
2020-300580-H01-RST
20-004778
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County).
  • Age ≥ 75 years old.
  • Current diagnosis of moderate or severe aortic stenosis by most recent (within 6 months at most) echocardiogram as defined by:
    • Moderate Aortic Stenosis (AS): 1.0 cm^2 < aortic valve area (AVA) ≤ 1.5 cm^2;
    • Severe AS: AVA ≤ 1.0 cm^2.


Exclusion Criteria:

  • Any cardiac surgery or major chest trauma within 4 weeks of pyrophosphate (PYP) scan (or myocardial infarct imaging).
  • Myocardial infarction within 4 weeks of PYP scan defined by typical angina, EKG changes and significant change in serial troponins.
    • Note that chronic troponin elevation is extremely common in cardiac amyloidosis.
  • Prior or current exposure to Plaquenil (Hydroxychloroquine).
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Disrupted Sleep in Somali Americans – Implications for Hypertension Risk (Somali OSA)

Study of Disrupted Sleep in Somali Americans

Virend Somers
All
18 years to 70 years old
This study is NOT accepting healthy volunteers
2022-307940-H01-RST
22-004192
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Self-identify as Somali.
  • Adult males and females who are older than 18 years of age.


Exclusion Criteria:
  

  • Anyone under 18 years or over 70 years.
  • Positive pregnancy.

Eligibility last updated 3/8/23.  Questions regarding updates should be directed to the study team contact.

 

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Phase 1 Study of KTX-1001, an Oral, First-In-Class, Selective, and Potent MMSET Catalytic Inhibitor that Suppresses H3K36me2 in Patients with Relapsed and Refractory Multiple Myeloma

KTX-100 MMSET Catalytic Inhibitor that Suppresses H3K36me2 in Patients with Relapsed and Refractory Multiple Myeloma

David Dingli
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-309578-P01-RST
22-010820
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Voluntarily provide informed consent prior to initiation of study specific activities.
  • ≥ 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) score ≤ 2.
  • Patients must have a confirmed diagnosis of RRMM (as per IMWG):
    • Patients must have received at least 3 prior lines of therapy as defined by IMWG, including a PI, an IMiD, and an anti-CD38 antibody;
    • Patients must have exhausted available therapeutic options that are expected to provide a meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance, or refusal of the therapy;
    • For expansion cohorts in Part B only: Have t(4;14) confirmed by standard of care FISH testing or GOF mutation in MMSET confirmed by local sequencing test.
  • Measurable disease, including at least 1 of the following criteria:
    • Serum M protein (detected by serum protein electrophoresis [SPEP]) ≥ 0.50 g/dL;
      • For patients with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA ≥ 0.50 g/dL (IgA will similarly be used for response).
    • Urine M protein (detected by urine protein electrophoresis [UPEP]) ≥ 200 mg/24 h;
    • Serum free light chain (sFLC) involved light chain ≥ 10 mg/dL (100 mg/L) provided sFLC ratio is abnormal;
    • ≥ 1 extramedullary lesion on imaging, including ≥ 1 lesion that is ≥ 1 cm in size and able to be followed by imaging assessments (Dose Escalation Only);
    • Bone marrow plasma cells ≥ 10% (Dose Escalation Only).
  • Recovery to Grade ≤ 1 for any nonhematologic toxicities due to prior therapy, excluding alopecia or Grade 2 neuropathy.
  • Ability and willingness to adhere to study visit schedule and protocol requirements.


Exclusion Criteria:

  • Treatment with the following therapies in the specified time period:
    • Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks prior to C1D1;
    • Cellular therapies (eg, chimeric antigen receptor T-cell) ≤ 8 weeks prior to C1D1;
    • < 100 days post autologous transplant (prior to first dose);
    • ≤ 6 months post allogenic transplant prior to C1D1 or if > than 6 months from allogenic transplant, no active graft-versus-host disease requiring treatment;
    • Major surgery ≤ 4 weeks from C1D1.
  • History of or current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis.
  • Active central nervous system (CNS) disease: patients with previously treated stable CNS disease are eligible.
  • Inadequate bone marrow function defined by:
    • ANC < 1000 cells/mm^3;
    • Platelets (PLT) < 75,000 cells/mm^3;
    • Hemoglobin < 8 g/dL (may be transfused provided no evidence of active bleeding).
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN).
  • Direct bilirubin > 1.5 × ULN, > 2 × ULN for patients with documented Gilbert’s syndrome.
  • Prothrombin time (PT) or partial thromboplastin time (PTT) international normalized ratio (INR) > 1.5 × ULN, OR INR > 1.5 × ULN or within target range if on prophylactic anticoagulation.
  • Creatinine clearance < 50 mL/min by Cockcroft-Gault formula.
  • Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Prophylactic medications, antimicrobials or antiretroviral therapies are permitted provided the agents are not prohibited per Section 6.4.6 and Appendix 1:
    • HIV-positive patients with CD4+ T-cell counts < 350 cells/μL or not on a stable antiretroviral regimen for > 4 weeks with a viral load > 400 copies/mL prior to enrollment may not be enrolled;
    • Hepatitis C virus (HCV)-positive patients who have not completed curative antiviral treatment and have a quantifiable viral load may not be enrolled;
    • Hepatitis B surface antigen (HBs-AG)-positive and hepatitis B core antigen (anti-HBc)-positive patients may be enrolled following a discussion with the Medical Monitor to discuss anti-hepatitis B virus (HBV) prophylaxis. Patients with chronic HBV infection should complete an anti-HBV therapy regimen with follow-up assessment for response and tolerability prior to initiating study medication.
  • Use of prohibited medications, including acid reducing agents and strong inhibitors or inducers of CYP3A4 (Appendix 1), within 14 days or 5 half-lives prior to starting KTX-1001.
  • Uncontrolled thromboembolic events or recent severe hemorrhage that, in the opinion of the Investigator or Medical Monitor would pose a risk to patient safety or interfere with the study evaluation, procedures or completion.
  • Any history of pulmonary embolism or deep vein thrombosis (DVT) within 1 month of enrollment. Therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of DVT if > 3 months from time of enrollment.
  • Active, unstable cardiovascular function; presence of any of the following:
    • Symptomatic ischemia;
    • Uncontrolled clinically significant conduction abnormalities (eg, patients with ventricular tachycardia on antiarrhythmics are excluded; patients with first degree atrioventricular or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded);
    • Congestive heart failure or New York Heart Association Class ≥ 3;
    • Myocardial infarction within 3 months prior to C1D1;
    • Uncontrolled hypertension f. QTc > 470 ms.
  • Active malignancy not related to myeloma that has required therapy in the last 3 years prior to enrollment or is not in complete remission. Exceptions to these criteria include successfully treated nonmetastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. Other similar malignant conditions may be discussed with and permitted by the Medical Monitor.
  • Malabsorption syndrome or other condition affecting oral absorption.
  • Men and women of reproductive potential who are unwilling to practice acceptable methods of effective birth control while on study through 6 months (women) or 3 months (men) after receiving the last dose of study drug. Acceptable methods of effective birth control include sexual abstinence (refraining from heterosexual intercourse; men, women); vasectomy; tubal ligation; or a condom with spermicide (men) in combination with barrier methods, hormonal birth control or intrauterine device (women):
    • Pregnancy, or females planning on becoming pregnant while on study or through 6 months after last study drug administration; or females who are lactating/breast feeding or who plan to breastfeed while on study through 6 months after last study drug administration;
    • Male patients must refrain from sperm donation, or attempt to conceive from study drug administration until 3 months after last dose of study drug.
  • History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the Investigator or Medical Monitor would pose a risk to patient safety or interfere with the study evaluation, procedures or completion, including inability to find alternative concomitant medications that may be potential risk for drug-drug interaction (DDI).
Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

SEntinel Lymph node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT) (SELECT)

A Study to Assess Endometrial Cancer Recurrence in Patients After 36 Months

Gretchen Glaser
Female
18 years and over
This study is NOT accepting healthy volunteers
2020-302327-P01-RST
20-010248
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria
•Preop:

  • ECOG performance status 0-1 or KPS >70%
  • Age ≥ 18 years
  • Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage confirmed at the enrolling institution
  • No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and pelvic +/- abdominal imaging)
  • Suitable candidate for surgery
  • Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
  • No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer
  • Approved and signed informed consent
  • No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer
  • No history of prior pelvic or abdominal radiotherapy

Exclusion Criteria
•Preop:

  • Extrauterine disease, gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage > I).
  • Contraindication for SLN mapping.
  • The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy.

Inclusion Criteria
•Postop:

  • Hysterectomy.
  • Bilateral salpingo-oophorectomy, unless already previously performed.
  • Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy).
  • Final pathology must show Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with ≥ 50% myometrial invasion or Grade 3 with < 50% myometrial invasion, including non-invasive disease).
  • Final pathology must show negative pelvic peritoneal cytology.
  • Adjuvant treatment as recommended by the multidisciplinary team must be
    as follows:
    o No adjuvant treatment; or
    o Intravaginal radiation only.

Exclusion Criteria
•Postop:

  • There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes.
  • Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC).
  • Hysterectomy is not performed.
  • Bilateral salpingo-oophorectomy is not performed, unless already previously performed.
  • Failed unilateral or bilateral SLN mapping.
  • Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy.
  • Patient undergoes a radical type C hysterectomy.
  • Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion < 50%.
  • Stage IB Grade 3 endometrioid cancer.
  • Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology.
  • Empty unilateral or bilateral sentinel lymph nodal packet(s).
  • Positive peritoneal cytology.
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer

ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC) (ACT-MBC)

Amrit Singh
All
18 years and over
This study is NOT accepting healthy volunteers
2020-302848-P01-MAIJ
21-001745
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease 2 ER+/HER2- patients prior to starting 2nd line therapy or beyond in the metastatic setting OR ER/PR/HER2-negative (Triple Negative) patients prior to starting any line of therapy in the metastatic setting.
  • Note: ER/PR/HER2 status is defined per the 2018 ASCO/CAP guidelines as follows: ER-positive and PR-positive is defined as ≥ 1% reactive cells by immunohistochemical staining. HER2 Negative Disease is defined by meeting one of the following criteria:
    • 0 or 1+ by IHC and not amplified by ISH;
    • 0 or 1+ by IHC and ISH not done;
    • 2+ by IHC and ISH results are:
      • < 6.0 HER2 signals/cell with HER2/CEP17 ratio < 2.0;
    • IHC not done and not amplified by ISH.
  • Measurable and/or non-measurable disease is allowed.
  • Male or female breast cancer is allowed.
  • Age > 18 years.
  • Willingness to provide mandatory blood specimens.
  • Willing to return to enrolling institution for follow up imaging at least once.


Exclusion Criteria:

  • Life expectancy of ≤ 6 months.
  • Inability to provide blood samples based on the judgment of the treating provider.

Eligibility last updated 12/20/23. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Mankato, MN