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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.

3500 Study Matches

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APAL2020SC, Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

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

Wendy Allen-Rhoades
All
up to 22 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-310014-P01-RST
22-011639
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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;

- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment related AML.

- 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.

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

Eligibility last updated 11/4/22. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery
Acute myelogenous leukemia, Cancer, Leukemia, Recurrent cancer
Acute myeloid leukemia, disease, B-cell acute lymphoblastic leukemia, Cancer treatment, Hematopoietic system, Inherited acute myeloid leukemia, Medical Oncology, Mixed phenotype acute leukemia, Myeloid leukemia co-occurrent with Down syndrome, Myeloid sarcoma, Refractory acute myeloid leukemia, T-cell acute lymphoblastic leukemia, Therapy related acute myeloid leukemia and myelodysplastic syndrome
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Understanding the Impact of Unproven Stem Cell Corrections on Attitudes and Behavioral Intent of Patients

Patient Perceptions of the Impact of Unproven Stem Cell Corrections

Zubin Master
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310019-H01-RST
22-011654
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Inclusion Criteria:

  • Different conditions based on the top 20 diseases as determined by patients seeking stem cells (Smith et al., 2020 Regen Med) (ResearchMatch permits the selection of participants based on specific conditions).
  • Equal numbers of women and men (ResearchMatch provides sex at birth).
  • Different states and rural/urban populations (ResearchMatch provides state information).
  • Diverse racial/ethnic backgrounds including minorities (ResearchMatch permits the selection of participants based on race and ethnicity).
  • Moderate and high SCI seekers (by administering a short email survey of 8 questions determining SCI seeking intent.
  • Participation will be determined based on desire for information about SCIs, race/ethnicity, geographic location, condition, and gender (equal numbers of women and men).


Exclusion Criteria:
 

  • < 18 years of age.

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

Eligibility last updated 11/4/22. Questions regarding updates should be directed to the study team contact.

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An Evaluation of the Intestinal Microbiome and Immune Function in Lymphoma

Evaluating Intestinal Microbiome and Immune Function in Lymphoma

Thomas Witzig
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310039-P01-RST
22-011731
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Inclusion Criteria:

  • Patients with a histologic diagnosis of:
    • Newly diagnosed;
    • Progressive;
    • Relapsed lymphoma (any NHL HL, or CLL histology) who are initiating or changing therapy (chemotherapy, radiotherapy, or clinical trial/ investigational agent), or who have measurable disease and are being expectantly monitored. Patients whose lymphoma is in remission and who are being monitored expectantly are eligible as a separate cohort.
  • Age > 18 years.
  • May be s/p autologous or allogeneic bone marrow transplant.
  • Ability to understand and willing to sign a written informed consent document.
  • Patients with a histologic diagnosis of relapsed lymphoma or multiple myeloma who are scheduled to undergo CAR T cell therapy (up to 25 patients).
  • Newly diagnosed, untreated DLBCL patients confirmed by pathologic review. 

​​


Exclusion Criteria:

  • Patients already receiving any investigational agents or chemotherapy at time of baseline sample collection.
  • Medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator.                               
  • Patients with CNS disease or lymphoma related to prior chemotherapy (new DLBCL cohort only).
  • Patients with hemoglobin level of 8 or below.

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

Eligibility last updated 3/17/23. Questions regarding updates should be directed to the study team contact.

 

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Effect of Ventilation and Filtration Control on Office Workers Performance and Health Outcomes

Workers Performance and Health Outcomes of Office Air Ventilation and Filtration Control

Bruce Johnson
All
18 years to 59 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-310054-P01-RST
22-011790
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Inclusion Criteria:

  • ≥ 18 and ≤ 59 years of age.
  • BMI ≥ 18.5.
  • Indoor office workers employed full-time at the Mayo Clinic or another business within and around Rochester, MN.
  • Report working a desk-based job, such as clerical and administrative staff.
  • Fully vaccinated and boosted against COVID-19.
  • Be willing to not wear a mask while in the office module.
  • Allowed to work from home for at least a whole week (5 consecutive workdays in Background Work-from-Home Condition).
  • Able to relocate to the WLL office during the workday, complete work in an open office space, be present for 80% of the total study for four consecutive work weeks, and be able to complete at least 80% daily tasks.
  • Each workday, short personal meetings/calls and lunch break outside the office is allowed, but the participants should spend no less than 6 hours per day in the office.
  • Be able to provide informed consent.


Exclusion Criteria:

  • Individuals who are lactating, pregnant, or intend to become pregnant during the study.
  • Shift-workers.
  • Individuals who are taking medications (either prescribed or over-the-counter) which may affect mental status.
  • Drug (illegal or prescription narcotic), nicotine, or alcohol dependency.
  • Asthma or allergies to any airborne pollutants, such as pollen and dust.
  • Individuals diagnosed with pre-existing respiratory, neurological, or severe sleep disorders given their potential impact on study outcomes;.
  • Individuals who have medical conditions associated with higher risk for severe COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html).

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

Eligibility last updated 11/8/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Device
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Evaluating the feasibility of a primary care-based treatment for restrictive eating disorders in children and adolescents in the health system

A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders

Jocelyn Lebow
All
7 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-310074-H01-RST
22-011880
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Inclusion Criteria:

  • Diagnosis of a DSM-5 restrictive eating disorder (anorexia nervosa or other specified feeding or eating disorder characterized by dietary restriction and/or weight loss or failure to make expected weight gains).
  • Eligible patients will have at least one caregiver who is also willing to participate in the study.
  • Eligible patients must receive primary care through one of 3 MCHS sites connected to the study: Onalaska/La Crosse, Redwing, and Faribault.


Exclusion Criteria:

  • Patients will be excluded who have received FBT in the past, and/or who report active suicidality.
  • Patients who become physically or psychiatrically unstable during the study will be re-evaluated and referred for appropriate treatment.
  • Patients will be excluded if their enrolled caregiver has active substance  dependence, mental health concerns that make it difficult to engage in treatment, or are perpetrators of abuse.

Eligibility last updated 11/10/22. Questions regarding updates should be directed to the study team contact.

Behavioral
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Safety and Feasibility of Autologous Induced Pluripotent Stem Cells of Cardiac Lineage in Subjects With Congenital Heart Disease

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage Delivered Into Heart Muscle for Congenital Heart Disease

Rebecca Ameduri
All
18 years to 40 years old
Phase 1
This study is NOT accepting healthy volunteers
2022-310135-H01-RST
22-012171
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Inclusion Criteria:


- Age 18 to 40 years old.

- Subject must be able to understand and provide informed consent.

- Univentricular congenital heart disease.

- End-stage systolic heart failure, defined as Class IV according to New York Heart
Association (NYHA) with abnormal visually estimated ejection fraction below 40%.

- Prognosis of 1 to 1.5 years survival at time of skin biopsy.

- The patient falls into one of the following categories:

- Currently listed for heart transplantation at an accredited program in the US but
has an expected waiting time for a suitable organ that is likely longer than
anticipated life-expectancy;

- Has been denied access to a heart transplantation at an accredited US
institution;

- Is currently on or planning to be on mechanical support as destination therapy.

- All guideline directed therapy available to the subject has been maximized, for a
minimum of 3 months prior to enrollment.

- Adequate social support system that facilitates subject participation in all study
required tests and procedures and supports the subject's ability to comply with
long-term study requirements.


Exclusion Criteria:

- No available autologous iPSC-CL as defined by the manufacturer's release criteria.
(This applies to Part II of the study and applies to the treatment arm only).

- History of symptomatic episodes of cardiac arrythmia requiring cardiac defibrillation
or escalation of medications.

- Heart failure with preserved ejection fraction.

- Heart failure due to co-morbid conditions (e.g., amyloidosis, valvular heart disease,
refractory anemia).

- QTc greater than 500 ms.

- Stage III or higher chronic kidney disease.

- History of liver cirrhosis.

- History of coronary artery disease.

- Uncontrolled diabetes mellitus.

- Any history of cancer.

- Contraindication for use of amiodarone for up to 3 months (treatment arm only).

- Contraindication for insertion of Insertable Cardiac Monitor.

- Contraindication for placement of LifeVest cardioverter defibrillator.

- Positive serology testing for HIV, Hepatitis B, Hepatitis C or Syphilis.

- Obesity with BMI greater than 30.

- Current alcohol or drug abuse precluding heart transplantation.

- Active infection requiring ongoing treatment.

- Contraindication to anesthesia.

- Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality of the data
obtained from the study.

- Inability or unwillingness of a participant to give written informed consent or comply
with study protocol.

- History of non-compliance.

- Inability to be accompanied around the clock for any part of the first 3 weeks post
product administration.

- Uncontrolled depression.

- Denied heart transplant due to social determinants.

- Current participation in another cardiac interventional clinical trial that could
confound the results of this study.

- Previous heart transplant.

Eligibility last updated 1/30/23. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine
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Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Patients With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study (BiCaZO)

BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study

Arkadiusz Dudek
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-310147-P01-RST
22-013003
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Inclusion Criteria:


- STEP 1
•SPECIMEN SUBMISSION INCLUSION CRITERIA

- Participants must have histologically confirmed melanoma that is stage III or IV,
unresectable, recurrent, or metastatic non-uveal melanoma OR Participants must have
histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) that is
either locally recurrent and non-amendable to curative therapy (e.g., radiation,
surgery) or metastatic. The primary tumor location must be the oropharynx, oral
cavity, hypopharynx, or larynx. Primary tumor site of nasopharynx (any histology) or
unknown primary tumor are not eligible.

- Note: For participants with primary oropharyngeal cancer, human papillomavirus
(HPV) or p16 status must be known prior to step 1 registration

- Participants must have disease presentation consistent with measurable disease. Note:
Current disease measurements will not be required until step 2 registration.

- Participants must have had documented progression within 12 weeks after the last dose
of PD-1 checkpoint inhibition-based therapy. Participants must have been receiving
checkpoint inhibition for a minimum of 6 weeks prior to progression. Participants who
recur during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant
anti-PD1 treatment are eligible if they have measurable disease and considered
unresectable.

- Participants with known human immunodeficiency virus (HIV)-infection must be receiving
anti-retroviral therapy and have an undetectable viral load test within 6 months prior
to step 1 registration

- Participants with evidence of chronic hepatitis B virus (HBV) infection must have
undetectable HBV viral load within 28 days prior to step 1 registration.

- Participants with a history of hepatitis C virus (HCV) infection must have no
detectable viral load within 28 days prior to step 1 registration.

- Participants must have recovered to baseline or ≤ Grade 1 Common Terminology Criteria
for Adverse Events (CTCAE) version (v) 5 toxicities related to any prior treatments,
unless adverse events are deemed clinically nonsignificant by the treating
investigator or stable on supportive therapy.

- Participants must be ≥ 18 years of age.

- Participants must have a Zubrod Performance Status 0 or 1.

- Participants must have adequate cardiac function. Participants with known history or
current symptoms of cardiac disease, or history of treatment with cardiotoxic agents,
must have a clinical risk assessment of cardiac function using the New York Heart
Association Functional Classification and must be class 2B or better to be eligible
for this trial.

- Have adequate tissue specimen from procedure obtained within 6 months prior to step 1
registration and after development of resistance to anti-PD-1/L1 therapy. Archival
tissue must consist of tumor block or at least 20 freshly cut serially sectioned and
numbered 4-5 micron unstained, positively-uncharged slides OR

Be willing to undergo research biopsy AND have tumor accessible for biopsy based on the
following criteria:

- Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies can be
obtained incidentally to a clinically necessary procedure and NOT for the sole purpose
of the clinical trial.

- Acceptable biopsy procedures are:

- Percutaneous biopsy with local anesthetic and/or sedation with an expected risk
of severe complications < 2%;

- Direct transoral biopsy (with or without local anesthetic and/or sedation) with
an expected risk of severe complications < 2%;

- Excisional cutaneous biopsy with local anesthetic and/or sedation with an
expected risk of severe complications < 2%;

- Biopsy with removal of additional tumor tissue during a medically necessary
mediastinoscopy, laparoscopy, gastrointestinal endoscopy, bronchoscopy or
craniotomy. No open surgical, laparoscopic or endoscopic procedure should be
performed solely to obtain a biopsy for this protocol;

- Removal of additional tumor tissue during a medically necessary surgical
procedure.

- Participants must have been offered the opportunity to participate in
specimen banking.

- Note: As a part of the Oncology Patient Enrollment Network (OPEN)
registration process the treating institution's identity is provided in
order to ensure that the current (within 365 days) date of institutional
review board approval for this study has been entered in the system.

- Participants must be informed of the investigational nature of this study and must
sign and give informed consent in accordance with institutional and federal guidelines.

- Participants with impaired decision-making capacity are eligible as long as their
neurological or psychological condition does not preclude their safe participation in
the study (e.g., tracking pill consumption and reporting adverse events to the
investigator).

- STEP 2 TREATMENT REGISTRATION INCLUSION CRITERIA

- Participants must have been eligible for step 1 registration.

- Participants must have had their tumor tissue submitted via the Southwest
Oncology Group (SWOG) Specimen Tracking System prior to step 2 registration.

- Participants registered during stage II of the protocol must have received
assignment to an open cohort from the SWOG Statistics and Data Management Center
based on their biomarker screening profile (not applicable for patients
registered during stage I of the protocol).

- Participants must have measurable disease. All measurable disease must be
assessed within 28 days prior to step 2 registration. All non-measurable disease
must be assessed within 42 days prior to step 2 registration. Note: All disease
must be assessed and documented on the Baseline Tumor Assessment Form (Response
Evaluation Criteria in Solid Tumors [RECIST] 1.1).

- For melanoma participants, computed tomography (CT) chest, abdomen and pelvis
must be obtained. For HNSCC participants, CT neck and chest must be obtained.
Further imaging (i.e., magnetic resonance imaging [MR] brain, CT abdomen/pelvis
or extremities, bone scan) will be performed as deemed appropriate by the
treating physician.

- Participants with treated brain metastases must have no evidence of progression
on the follow-up brain imaging after central nervous system (CNS)-directed
therapy.

- Participants with treated brain metastases must have discontinued steroid
treatment at least 14 days prior to step 2 registration.

- Participants must have a history and physical examination performed within 28
days prior to step 2 registration.

- Participants must be able to take oral medication without breaking, opening,
crushing, dissolving or chewing capsules.

- Leukocytes ≥ 3,000/uL (within 28 days prior to step 2 registration).

- Absolute neutrophil count ≥ 1,500/uL (within 28 days prior to step 2
registration).

- Platelets ≥ 100,000/uL (within 28 days prior to step 2 registration).

- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x ULN
for participants with Gilbert's disease (within 28 days prior to step 2
registration).

- Aspartate aminotransferase (AST) ≤ 3 x institutional ULN (within 28 days prior
to step 2 registration).

- Alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to
step 2 registration).

- Urinalysis: For baseline value (no required value for eligibility).

- Fridericia corrected QT interval (QTcF) ≤ 470 milliseconds on screening
electrocardiogram (ECG) (within 28 days prior to step 2 registration).

- Creatinine ≤ 3 x institutional ULN OR measured (OR calculated) creatinine
clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen
must have been drawn and processed within 28 days prior to Step 2 registration.


Exclusion Criteria:


- STEP 1
•SPECIMEN SUBMISSION EXCLUSION CRITERIA

- Participants must not have an active infection requiring systemic therapy (except HBV,
HCV or HIV as mentioned above).

- Participants must not have received surgery, chemotherapy, radiation therapy, biologic
agents, or steroids within 14 days prior to step 1 registration.

- Participants must not have received more than one prior primary radiotherapy regimen,
curative or adjuvant, to the head and neck, with the additional following criteria:

- If the primary radiation is combined with chemotherapy, a minimum of 16 weeks
will be required to have elapsed between the end of radiotherapy and step 1
registration. If the radiation is given alone, a minimum of 8 weeks will be
required to have elapsed between the end of radiotherapy and step 1 registration;

- Additional palliative radiotherapy regimens are permitted but cannot have been
administered to previously treated tissue (i.e., overlapping fields are excluded)
and must be completed at least 4 weeks prior to step 1 registration;

- Treatment areas should be healed with no sequelae from radiation therapy (RT)
that would predispose to fistula formation;

- Participants must not have received prior treatment with anti-VEGF therapies for any
reason;

- Participants must not have any known significant organ disfunction that, in the
opinion of the treating investigator, may impact suitability for receiving combination
nivolumab/cabozantinib treatment.

- Participants must not have active autoimmune disease requiring systemic steroids
(equivalent of > 10mg of prednisone) or other immune suppression. Exceptions:

- Type 1 diabetes mellitus;

- Hypothyroidism only requiring hormone replacement;

- Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic
treatment;

- Conditions not expected to recur in the absence of an external trigger.

- Participants must not have received an organ allograft.

- Participants must not have a history of hemoptysis (defined as ≥ 1/2 tsp of bright
red blood per day) or tumor bleeding within 90 days prior to step 1 registration.

- Participants must not have known central lung lesions involving major blood vessels
(arteries or veins) or a tumor encasing major blood vessels (e.g., carotid artery).

- Participants must not require concomitant anticoagulation with coumarin agents (e.g.,
warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor
betrixaban, or platelet inhibitors (e.g., clopidogrel).

- Participants must not require anticoagulants except for the following:

- Prophylactic use of low-dose aspirin for cardio-protection (per local
applicable guidelines) and low-dose low molecular weight heparins (LMWH);

- Therapeutic doses of LMWH or anticoagulation with direct factor Xa
inhibitors, rivaroxaban, edoxaban, or apixaban in participants without known
brain metastases who are on a stable dose of the anticoagulant for at least
1 week prior to step 1 registration without clinically significant
hemorrhagic complications from the anticoagulation regimen or the tumor.

- Participants must not have evidence of preexisting uncontrolled hypertension prior to
step 1 registration as documented by 2 baseline blood pressure readings taken at least
30 minutes apart within 28 days prior to step 1 registration. The baseline systolic
blood pressure readings must be ≤ 150 mmHg and the baseline diastolic blood pressure
readings must be ≤ 90 mmHg. Participants on antihypertensive therapies with
controlled blood pressure are eligible.

- Participants must not have a prior or concurrent malignancy whose natural history or
treatment (in the opinion of the treating physician) has the potential to interfere
with the safety or efficacy assessment of the investigational regimen.

- Participants must not be pregnant or nursing due to the known safety profiles of the
drugs in this study. Individuals who are of reproductive potential must have agreed to
use an effective contraceptive method with details provided as a part of the consent
process. A person who has had menses at any time in the preceding 12 consecutive
months or who has semen likely to contain sperm is considered to be of "reproductive
potential. In addition to routine contraceptive methods, "effective contraception"
also includes refraining from sexual activity that might result in pregnancy and
surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention)
including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion and
vasectomy with testing showing no sperm in the semen.

- STEP 2 TREATMENT REGISTRATION EXCLUSION CRITERIA

- Participants must not have experienced any significant health changes that, in the
opinion of the treating investigator, may impact continued suitability for receiving
combination nivolumab/cabozantinib treatment.

- Participants must not have received more than one prior primary radiotherapy regimen,
curative or adjuvant, to the head and neck, with the additional following conditions:

- If the primary radiation is combined with chemotherapy, a minimum of 16 weeks
will be required to have elapsed between the end of radiotherapy and step 2
registration. If the radiation is given alone, a minimum of 8 weeks will be
required to have elapsed between the end of radiotherapy and step 2 registration;

- Additional palliative radiotherapy regimens are permitted but cannot have been
administered to previously treated tissue (i.e., overlapping fields are excluded)
and must be completed at least 4 weeks prior to step 2 registration.

- Treatment areas should be healed with no sequelae from RT that would predispose
to fistula formation.

- Participants must not have received investigational agents or monoclonal antibodies
(except Food and Drug Administration [FDA] approved supportive care antibodies, such
as denosumab) within 28 days prior to step 2 registration.

- Participants must not have received any prior treatment with anti-VEGF based therapies.

- Participants must not have received administration of a live, attenuated vaccine
within 30 days prior to step 2 registration. Note: Participants may have received a
messenger ribonucleic acid (mRNA) or viral vector-based COVID-19 vaccine within 30
days prior to step 2 registration.

- Participants must not have received administration of any strong CYP3A4 inducers, such
as but not limited to rifampin, carbamazepine, enzalutamide, mitotane, phenytoin and
St. John's wort, within 14 days prior to step 2 registration.

- Participants must not have received administration of any strong CYP3A4 inhibitors,
such as but not limited to clarithromycin, itraconazole, ketoconazole, grapefruit
juice, indinavir, nelfinavir, ritonavir, nefazodone, saquinavir, and telithromycin,
within 5 times the half-life of the CYP3A inhibitor prior to step 2 registration.

- Participants must not have malabsorption syndrome.

- Participants must not have central lung lesions involving major blood vessels
(arteries or veins) or a tumor encasing major blood vessels (e.g., carotid artery).

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

Eligibility last updated 11/21/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Procedure/Surgery
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The effects of acute and chronic exercise on the immune phenotype of chronic lymphocytic leukemia patients

Immune Phenotype of Chronic Lymphocytic Leukemia Patients Effects From Acute and Chronic Exercise

Neil Kay
All
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-310156-P01-RST
22-012246
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Inclusion Criteria:

  • ≥ 18 and ≤ 80 years of age.
  • Diagnosis of CLL will be required to participate in Aim 2 of this study.


Exclusion Criteria:

  • Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular, musculoskeletal, or pulmonary disease.

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

Eligibility last updated 12/7/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Other
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Gene transcriptional profile of normal biceps muscle

Normal Biceps Muscle Gene Transcriptional Profile

Peter Rhee
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310205-H01-RST
22-012114
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Inclusion Criteria:

  • ≥ 18 years or age.
  • Undergoing open cubital tunnel release at the level of their elbow will be selected to collect muscle biopsies of their biceps muscle.


Exclusion Criteria:

  • Previous history of peripheral nerve injury involving the musculocutaneous nerve.
  • Previous history of surgery at the level of the arm (fractures around the shoulder or elbow).
  • Medical history of neurological diseases.

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

Eligibility last updated 11/29/22. Questions regarding updates should be directed to the study team contact.

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Clinical Safety and Performance of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation (VISTA-US) (VISTA-US)

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation (VISTA)

Charanjit Rihal
All
18 years and over
Phase 1, Early Feasibility
This study is NOT accepting healthy volunteers
2022-310255-P01-RST
22-012726
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Inclusion Criteria:

  • Moderate or severe tricuspid valve regurgitation of primary or secondary etiology.
  • Subject is adequately treated with medical therapy for heart failure 30 days prior to index procedure, including a diuretic.
  • Heart Team determines patient is a recommended candidate for the VDyne System.
  • Age 18 years or older.
  • Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for
  • treatment with the VDyne System.


Exclusion Criteria:


VDYNE SYSTEM SUITABILITY

  • Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs.
  • Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed.
  • Hypersensitivity to nickel or titanium.

Clinical Exclusion Criteria (assessed by pre-procedural imaging):

  • Left Ventricular Ejection Fraction (LVEF) < 30%.
  • Severe RV dysfunction.
  • Significant abnormalities of the tricuspid valve and sub-valvular apparatus.
  • Sepsis including active infective endocarditis (IE) (within last 6 months).
  • Right ventricular or atrial thrombus or vegetation.
  • Severe tricuspid annular or leaflets calcification.
  • Systolic pulmonary hypertension with systolic pulmonary artery pressure ≥70 mmHg.

CONCOMITANT PROCEDURES

  • Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.
  • Any planned surgery or interventional procedure within the period of 30 days prior to 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.
  • Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
  • Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
  • Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
  • Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
  • Prior tricuspid valve surgery or catheter-based therapy with permanent residual devices implanted that would preclude delivery or implantation of the VDyne Valve (e.g., valve replacement, edge to edge repair).
  • Severe valvular heart disease requiring intervention other than the tricuspid valve.
  • Known significant intracardiac shunt (e.g., septal defect) (PFO's without significant shunts are allowed).

COMORBIDITIES

  • Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure.
  • Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids).
  • Acute myocardial infarction (AMI) within 30 days.
  • Significant renal dysfunction (eGFR<30 ml/min/1.73m^2) or on dialysis.
  • End-stage liver disease (MELD > 11 / CHILD class C).
  • Bleeding requiring transfusion within 30 days.
  • Coagulopathy or other clotting disorder that cannot be medically managed.
  • Chronic immunosuppression or other condition that could impair healing response.
  • Any of the following: leukopenia, chronic anemia (Hgb < 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy
  • Unwilling to receive blood products.

General


Exclusion Criteria:

  • Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically.
  • Life expectancy less than 12 months due to non-cardiac comorbidities.
  • Treatment is not expected to provide benefit (futile).
  • Current IV Drug user (must be free drug abuse for > 1 year).
  • Pregnant, lactating or planning pregnancy within next 12 months. (female of child-bearing potential use two reliable contraceptive methods during the study -hormonal methods such as pill and condom).
  • Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees).
  • Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study.
  • Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted.
  • Patient unable or unwilling to comply with study required testing and follow-up visits.

Eligibility last updated 4/14/23. Questions regarding updates should be directed to the study team contact.

Device
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Mayo Clinic — Rochester, MN

Engaging Adolescents in Decisions About Return of Genomic Research Results

Engaging Adolescents in Decisions About Return of Genomic Research Results

Michelle McGowan
All
13 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-310294-P01-RST
22-012883
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Inclusion Criteria:

  • Assenting adolescents (13-17 years).
  • Consenting adolescents (18-21 years).
  • Parent / legal guardian of assenting or  consenting adolescent.
  • Ability to participate in remote study visits, if applicable.


Exclusion Criteria:

  • Individuals who do not meet inclusion criteria.
  • Those who do not communicate in English.
  • Individuals with developmental disabilities that interfere with their ability to make independent decisions.
  • Participants whose permanent address is more than 100 miles from Cincinnati Children's Hospital Medical Center.

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

Eligibility last updated 5/11/23. Questions regarding updates should be directed to the study team contact.

Genetic
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Mayo Clinic — Rochester, MN

Assessment of the Mayo Clinic Vestibular Schwannoma Quality of Life (VSQOL) Index (VSQOL)

Mayo Clinic Vestibular Schwannoma Quality of Life Index Assessment

Kathleen Yost
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310317-H01-RST
22-012993
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Inclusion Criteria:

  • Able to read English fluently.
  • Can consent for themselves.
  • Age 18 years or older.
  • Diagnosis of vestibular schwannoma (also called acoustic neuroma).
  • Prior enrollment in IRB protocol 21-003059.


Exclusion Criteria:

  • Lack of capacity to consent since enrollment in IRB protocol 21-003059.
  • Unable to participate in an interview by Zoom.

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

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

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Mayo Clinic — Rochester, MN

Computer Aided Auscultation (CAA) of Phonoenterogram (PEG) PEG-CAAe for noninvasive diagnosis of patients with bowel diseases

Noninvasive Diagnosis of Patients With Bowel Diseases with Computer Aided Auscultation of Phonoenterogram

Shivaram Poigai Arunachalam
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310381-H01-RST
22-013060
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Inclusion Criteria:

  • Healthy male and female volunteers ≥ 18 years of age.
  • Patients diagnosed with irritable bowel syndrome (IBS) ≥ 18 years of age.
  • Patients with risk of developing POI or with clinical diagnosis ≥ 18 years of age.
  • Patients with evidence of partial bowel obstruction ≥ 18 years of age.


Exclusion Criteria:
 

  • Inability or unwillingness to participate in study.
  • Age ≤ 17 years old.

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

Eligibility last updated 12/19/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Occurrence of Shared Decision Making (SDM) in Unhurried Conversations

Characteristics of Unhurried Conversations and Shared Decision Making in Clinical Encounters

Victor Montori
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310615-H01-RST
23-000764
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Inclusion Criteria
•Patients:

  • Adults ≥ 18 years.
  • Have an appointment scheduled in primary care.

Inclusion Criteria
•Clinicians:

  • Clinicians who meet with patients in primary care.

 


Exclusion Criteria:

  • Major barriers to providing informed consent (i.e., dementia, severe hearing or visual impairment).

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

Eligibility last updated 1/23/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Cardiorespiratory responses to exercise in adults with post-acute sequelae of COVID-19

Effects of Long-COVID on Breathing During Exercise

Michael Joyner
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310737-H01-RST
23-001138
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Inclusion Criteria:
 

  • ≥ 18 years of age.
  • No additional confounding cardiorespiratory, metabolic, or musculoskeletal conditions.   
  • All inclusion criteria will be at the discretion of the principal investigator.


Exclusion Criteria:
 

  • < 18 years of age.

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

Eligibility last updated 1/31/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Novel 3D Model for Patient Surgical Airway Education

3D Anatomic Models of the Upper Airway for Surgical Airways

Eric Moore
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310743-H01-RST
23-001189
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Inclusion Criteria:

  • Patients age ≥ 18 years.
  • Patients who previously underwent a total laryngectomy or tracheostomy by an Otorhinolaryngology-Head and Neck Surgery department provider at Mayo Clinic Rochester [VAKM(M3] between January 1st, 1950 – present.
  • Patients who plan to undergo a total laryngectomy or tracheostomy by an Otorhinolaryngology-Head and Neck Surgery department provider at Mayo Clinic Rochester.
  • Patients with capacity to consent to the study.

Exclusion criteria:

  • Patients who declined Minnesota research authorization for the retrospective patient identification.

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

Eligibility last updated 1/31/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Prognostic Ability of Magnetocardiography (MCG) in Patients Undergoing Cardiac Catheterization

Mesuron Avalon-H90 MCG Device Magnetocardiography Utility Measurement in Cardiac Catheterization

Mohamad Adnan Alkhouli
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310897-H01-RST
23-001785
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Inclusion Criteria:

  • Patients presenting to the catheterization laboratory to undergo non-emergent cardiac catheterization procedures including coronary angiography, percutaneous coronary intervention, right heart cath, ablation, myocardial biopsy.
  • Adult patients (18 years old or older).
  • Patient willing and able to give informed consent.


Exclusion Criteria:
 

  • Emergent procedure.
  • ST elevation > 1 mm on any two contiguous ECG leads.
  • Hemodynamic instability (SBP > 220 or < 80, HR > 160).
  • Patients < 18 years old (children).
  • Patients known or suspected to be pregnant.
  • Incarcerated patients (FMC patients).
  • Patients with a pacemaker or defibrillator.
  • Metal implants in the body (that are not MRI safe).
  • Patients that are unable to lie down in the MCG machine or stay still.
  • Patients who are unable to understand the informed consent process (ex: non-English speakers without an available interpreter, cognitive delay).
  • Patients without the capacity to provide written informed consent.

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

Eligibility last updated 2/17/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction (MI) (i-STAT hs-TnI)

Abbott i-STAT High Sensitivity Troponin I Study (i-STAT hs-TnI)

Leslie Donato
All
18 years and over
This study is NOT accepting healthy volunteers
2023-311107-P01-RST
21-008237
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Inclusion Criteria:


- Subject is 18 years of age or older.

- Presenting to the ED with signs and symptoms suggestive of ACS: Acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure without apparent non-cardiac source; Shortness of breath, nausea, vomiting, fatigue/malaise; other equivalent discomfort suggestive of an MI (in accordance with the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines).

- ECG ordered as part of the standard of care.


Exclusion Criteria:


- Previously enrolled in the study.

- Enrolled in any interventional clinical trial (within the last 30 days).

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

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

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Mayo Clinic — Rochester, MN

A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone to Improve Persistence With Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN) (ASPEN)

Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study

Mina Hanna
Female
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2023-311206-P01-ALCL
23-003413
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Inclusion Criteria:

  • Participants must be female and have Stage I, II, or III hormone receptor positive breast cancer based on clinical or pathologic evaluation.
  • Participants must have been pre- or peri-menopausal at the time of breast cancer diagnosis by satisfying one of the following:
    • had a menstrual period (by self-report) within the 12 months before breast cancer diagnosis; or
    • had a serum or plasma estradiol and/or follicle stimulating hormone (FSH) concentration consistent with premenopausal status (based on institutional standards) within the 12 months before breast cancer diagnosis or when checked after breast cancer diagnosis.
  • Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole; within 14 days prior to randomization or be planning to start initial treatment with standard of care oral ET within 14 days after randomization.
  • Participants who currently have ovarian function (estradiol above the postmenopausal range) must be planning to undergo ovarian suppression or ablation concomitantly with oral ET medication, starting before or at the same time as oral ET initiation.
  • Participants with chemotherapy-induced amenorrhea or ovarian failure at time of registration must be planning to start ovarian suppression or ablation if they have recurrence of ovarian function during study participation (circulating estradiol concentration in the premenopausal range or recurrence of menses).
  • Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization NOTE: Concomitant radiotherapy at the time of randomization and/or during study participation is allowed.
  • Participants who received chemotherapy must have finished it at least 14 days prior to randomization.
    • NOTE: Concomitant maintenance targeted or biologic therapy (e.g., human epidermal growth factor receptor 2 [anti-HER2] therapy, poly-ADP ribose polymerase [PARP] inhibitor therapy, CDK4/6 inhibitor therapy, osteoclast inhibitor therapy) at the time of randomization and/or during study participation is allowed.
  • Participants must be ≥ 18 years of age.
  • Participants must have a complete medical history within 60 days prior to randomization.
  • Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English or Spanish.
  • Participants must:
    • agree to complete PROs at all scheduled assessments; and
    • complete the pre-registration (baseline) PRO forms within 14 days prior to randomization.
  • Participants must be able to complete symptom questions on a web browser (on a smartphone, tablet, or computer) or respond via voice on a telephone in English or Spanish. Participants must agree to complete symptom questions at all scheduled assessments.
    • NOTE: Participants who do not have access to the internet and who cannot receive telephone calls for interactive voice response system (IVRS) assessments are not eligible.
  • Participants must be offered the opportunity to participate in specimen banking for translational medicine. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG). specimen tracking system.
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.


Exclusion Criteria:

  • Participants must not have distant metastatic breast cancer.
  • Participants who have started or plan to start treatment with tamoxifen during study participation must not have received prior tamoxifen for treatment or prevention of breast cancer.
  • Participants who have started or plan to start treatment with an aromatase inhibitor during study participation must not have received prior aromatase inhibitor therapy for treatment or prevention of breast cancer.
  • Participants must not be taking or planning to take oral estrogen-or progesterone-containing treatments during study participation.

NOTES: 

  • Participants who start or plan to start treatment with an aromatase inhibitor may have previously received tamoxifen for prevention of breast cancer or treatment of a prior cancer.
  • Participants may have received prior treatment with an aromatase inhibitor for infertility treatment.
  • Participants must not be planning to become pregnant during the 80 weeks of study participation.
  • Participants must not receive additional anti-cancer treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial.
  • Participants must not have a non-breast malignancy for which they are currently receiving treatment.

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

Eligibility last updated 3/16/23. Questions regarding updates should be directed to the study team contact.

Behavioral, Procedure/Surgery, Other
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Mayo Clinic Health System — Albert Lea, MN

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 (AMXT 1501)

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

Terence Burns
All
18 years and over
ERROR, First In Human
This study is NOT accepting healthy volunteers
2022-308350-P01-RST
22-005690
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Clinical and radiographic evidence suggesting a diagnosis of a diffuse high grade glioma (HGG), or a prior diagnosis of a diffuse glioma.
  • Planned subtotal resection due to tumor location, size, or other clinical indication deemed appropriate by the surgeon.
  • Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of ceerebal spinal fluid (CSF) and blood samples collected on this protocol. Willing to remain in the hospital at Mayo Clinic (Rochester, MN) for three days added to their standard post-operative stay to undergo longitudinal microdialysis.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without transfusion within 7 days preceding the lab assessment (obtained ≤ 14 days prior to registration).
  • Platelet ≥ 100 x 10^9/L, without transfusion within 7 days preceding the lab assessment (obtained ≤ 14 days prior to registration)
  • Hemoglobin ≥ 9 g/dL, without transfusion support within 7 days preceding the lab assessment (obtained ≤ 14 days prior to registration).
  • Activated partial thromboplastin time/ partial thromboplastin time (aPTT/PTT) ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (obtained ≤ 14 days prior to registration)
  • Total serum bilirubin ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration).
  • The patient is clinically euthyroid.
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≤ 60 mL/min/1.73 m^2 for patients with serum creatinine levels above 1.5 x ULN (obtained ≤ 14 days prior to registration).
  • Negative serum or urine pregnancy test is required for female subjects of childbearing age.


Exclusion Criteria:

  • Patients who are not appropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings.
  • Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped.
  • Participants who are unable to swallow tablets or who are at risk for impaired absorption of oral medication.
    • NOTE: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection.
  • Patients with known hypersensitivity or allergy to DFMO or AMXT 1501.
  • Contraindication to MRI or administration of gadolinium.

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

 

Device, Drug, Procedure/Surgery
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Mayo Clinic — Rochester, MN