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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.

3290 Study Matches

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Neurodevelopmental Outcomes in Children with Hypoplastic Left Heart Syndrome Who Underwent Delivery of Autologous Umbilical Cord Derived Mononuclear Cells During Cardiac Surgery: A Pilot Study

A Study to Evaluate Neurodevelopmental Outcomes in Children with Hypoplastic Left Heart Syndrome After Delivery of Autologous Umbilical Cord Derived Mononuclear Cells During Cardiac Surgery

Adam Cassidy
All
2 years to 65 years old
This study is NOT accepting healthy volunteers
2021-304768-H01-RST
21-005351
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Inclusion Criteria;

  • Children with Hypoplastic Left Heart Syndrome who received umbilical cord derived mononuclear cells during cardiac surgery.
  • Children with Hypoplastic Left Heart Syndrome, matched in age and cardiac medical/surgical history, who did not receive mononuclear cells during surgery.
  • Ages 2 - 5.
  • Parent(s) fluent in English and/or Spanish.


Exclusion Criteria:

  • Status post heart transplant.

 

 

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Improving Ultrasonic Diagnosis and Monitoring of Osteochondritis Dissecans

Ultrasound for Osteochondritis Dissecans

Shawn ODriscoll
All
10 years to 45 years old
This study is NOT accepting healthy volunteers
2021-304782-H01-RST
21-009419
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Inclusion Criteria:

  • Patients who are 10 to 45 years old and of both sexes.
  • Patients with a diagnosis of OCD of the capitellum ICRS Grades 3 or 4 via standard-of-care X-ray CT or MRI, irrespective of the size or location of the lesion.
  • Patients who are scheduled to undergo surgery for the treatment of the OCD lesion, irrespective of the procedure.


Exclusion Criteria:
 

  • Patients with other current or prior elbow pathology.
  • Patients with prior history of elbow surgery.
  • Patients who do not consent to participate.

Eligibility last updated 9/3/21. Questions regarding updates should be directed to the study team contact.

 

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AAML1831, A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations (AAML1831)

A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib to To Treat Newly-diagnosed AML with or without FLT3 Mutations

Mira Kohorst
All
up to 22 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-304791-P01-RST
21-005419
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Inclusion Criteria:


- All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part
A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens
must be done according to the Manual of Procedures

- Patients must be less than 22 years of age at the time of study enrollment

- Patient must be newly diagnosed with de novo AML according to the 2016 World Health
Organization (WHO) classification with or without extramedullary disease

- Patient must have 1 of the following:

- >= 20% bone marrow blasts (obtained within 14 days prior to enrollment)

- In cases where extensive fibrosis may result in a dry tap, blast count
can be obtained from touch imprints or estimated from an adequate bone
marrow core biopsy

- < 20% bone marrow blasts with one or more of the genetic abnormalities
associated with childhood/young adult AML as provided in the protocol
(sample obtained within 14 days prior to enrollment)

- A complete blood count (CBC) documenting the presence of at least 1,000/uL
(i.e., a white blood cell [WBC] count ≥ 10,000/uL with ≥ 10% blasts or a
WBC count of ≥ 5,000/uL with ≥ 20% blasts) circulating leukemic cells
(blasts) if a bone marrow aspirate or biopsy cannot be performed (performed
within 7 days prior to enrollment)

- ARM C: Patient must be >= 2 years of age at the time of Late Callback

- ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular
Oncology

- ARM C: Patient does not have any congenital long QT syndrome or congenital heart block

- ARM C: Females of reproductive potential must agree to use effective contraception
during treatment and for at least 6 months after the last dose of gilteritinib

- ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib
and for 2 months after the last dose of gilteritinib

- ARM C: Males of reproductive potential must agree to use effective contraception
during treatment and for at least 4 months after the last dose of gilteritinib

- ARM D: Patient must be ≥ 2 years of age at the time of Late Callback

- ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating
mutations as reported by Foundation Medicine

- ARM D: Females of reproductive potential must agree to use effective contraception
during treatment and for at least 6 months after the last dose of gilteritinib

- ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib
and for 2 months after the last dose of gilteritinib

- ARM D: Males of reproductive potential must agree to use effective contraception
during treatment and for at least 4 months after the last dose of gilteritinib

- NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who
transfer to Arm C or Arm D are not eligible

- NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment

- NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking

- NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to
diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental
retardation)

- NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would
prevent computer use or recognition of visual test stimuli

- 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.


Exclusion Criteria:


- Fanconi anemia

- Shwachman Diamond syndrome

- Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21

- Telomere disorders

- Germline predispositions known, or suspected by the treating physician to increase
risk of toxicity with AML therapy

- Any concurrent malignancy

- Juvenile myelomonocytic leukemia (JMML)

- Philadelphia chromosome positive AML

- Mixed phenotype acute leukemia

- Acute promyelocytic leukemia

- Acute myeloid leukemia arising from myelodysplasia

- Therapy-related myeloid neoplasms

- Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection
fraction (EF) < 50% (preferred method Biplane Simpson's EF) or if EF unavailable,
shortening fraction (SF) < 24%. *Note: if clinically safe and feasible, repeat
echocardiogram is strongly advised in order to confirm cardiac dysfunction following
clinical stabilization, particularly if occurring in the setting of sepsis or other
transient physiologic stressor. If the repeat echocardiogram demonstrates an EF >=
50%, the patient is eligible to enroll and may receive an anthracycline-containing
Induction regimen

- Administration of prior anti-cancer therapy except as outlined below:

- Hydroxyurea

- All-trans retinoic acid (ATRA)

- Corticosteroids (any route)

- Intrathecal therapy given at diagnosis

- In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be
avoided from the time of enrollment until it is determined whether the patient
will receive gilteritinib. Patients receiving gilteritinib will be required to
avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the
study treatment

- Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs. A pregnancy test is required for female
patients of childbearing potential

- Lactating females who plan to breastfeed their infants

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation

- ARM D: Patient does not have any congenital long QT syndrome or congenital heart block

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

Behavioral, Drug, Procedure/Surgery
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Cell Biological Interrogation of Patient-derived AVM Cell Lines (AVM)

Cell Biological Interrogation of Patient-derived Arteriovenous Malformation Cell Lines

David Daniels
All
Not specified
This study is NOT accepting healthy volunteers
2021-304805-H01-RST
21-005465
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Inclusion Criteria:

  • Adult and pediatric patients.
  • Undergoing surgical resection of their brain AVM.
  • Have not undergone previous stereotactic radiosurgery or endovascular embolization.  


Exclusion Criteria:

  • Have undergone previous stereotactic radiosurgery or endovascular embolization.

Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.

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CORT125134-551, A Phase 1b, Open-Label Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production

Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production

Mabel Ryder
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-304821-P01-RST
21-010660
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Inclusion Criteria:


- Histologically or cytologically confirmed ACC (advanced unresectable and/or
metastatic)

- Measurable disease based upon RECIST v1.1 as determined by the Investigator.

- Documented GC excess (too much cortisol).

- For patients who have received mitotane within 3 months prior to screening, mitotane
levels must be <4 mg/L at screening.

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

- Adequate organ and bone marrow function (determined through blood and urine tests)

- Negative pregnancy test for patients of childbearing potential at the Screening and
every 6 weeks (+ or
•7 days) in female patients of childbearing potential.


Exclusion Criteria:


- Major surgery within 4 weeks prior to enrollment. If the participant underwent major
surgery, they must have recovered adequately prior to starting study treatment.

- Have received and responded (complete response [CR] or partial response [PR]) to prior
treatment with any prior checkpoint inhibitor or any other agents targeting T-cell
stimulation pathways

- Taking a concomitant medication that is a strong Cytochrome P450 3A (CYP3A) inducer,
or that is a substrate of CYP3A with a narrow therapeutic index

- Known untreated parenchymal brain metastasis or have uncontrolled central nervous
system (CNS) metastases. Patients must not require steroids and must be neurologically
stable without corticosteroids for a minimum of 3 weeks prior to the commencement of
the study. Patients with neurologic symptoms must undergo a CT/MRI to rule out occult
CNS metastases.

- Requirement for chronic systemic GC treatment, such as active autoimmune disease
requiring systemic treatment (corticosteroids or other immunosuppressive medication)

- Patients requiring inhaled glucocorticoids but have no other alternative treatment
option if their condition deteriorates during the study.

- Clinically relevant toxicity from prior systemic cytotoxic therapies or radiotherapy
that in the opinion of the Investigator has not resolved to NCI-CTCAE v5.0 Grade 1 or
less prior to the first dose of relacorilant.

- Treated with the following prior to the first dose of relacorilant:

1. Any investigational product, systemic anticancer therapy, or radiation therapy
within 21 days

2. Antibodies or anticancer vaccines within 60 days

3. Mifepristone or other GR antagonists within 5 half-lives of these medications

4. Adrenostatic medications within 5 half-lives of these medications

- History of severe hypersensitivity to another monoclonal antibody

- Other concurrent cancer or a history of another invasive malignancy within the last 3
years that has a likelihood of recurrence of >30% within the next 5 years. Adequately
treated basal and squamous skin cancers, ductal carcinoma in situ, cervical cancer,
prostate cancer, non-muscle invasive urothelial cancer or other tumors curatively
treated with no evidence of disease are permissible.

- Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis
C virus or hepatitis B virus including: Chronic or active hepatitis B as diagnosed by
serologic tests. In equivocal cases, hepatitis B or C polymerase chain reaction may be
performed and must be negative for enrollment.

- Clinically significant uncontrolled condition(s) or a condition which, in the opinion
of the Investigator, may confound the results of the trial or interfere with the
patient's participation, including but not limited to:

1. Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction
3 months before study entry.

2. Active infection that requires parenteral antibiotics.

3. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.

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WO42758 - A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients with Metastatic Colorectal Cancer (Intrinsic) (Intrinsic)

A Study Evaluating the Safety and Effectiveness of Therapies in Patients with Metastatic Colorectal Cancer

Joleen Hubbard
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-304824-P01-RST
21-006012
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Inclusion Criteria:


- Signed next-generation sequencing (NGS) Biomarker Eligibility Informed Consent Form

- Age >= 18 years at time of signing Informed Consent Form

- Biomarker eligibility as determined at a College of American Pathologists/clinical
laboratory improvement amendments (CAP/CLIA)-certified or equivalently accredited
diagnostic laboratory using a validated test

- Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1

- Life expectancy >= 3 months, as determined by the investigator

- Histologically confirmed adenocarcinoma originating from the colon or rectum

- Metastatic disease

- Prior therapies for metastatic disease

- Ability to comply with the study protocol, in the investigators judgment

- Measurable disease (at least one target lesion) according to Response Evaluation
Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

- Availability of an archival tissue sample for exploratory biomarker research

- Adequate hematologic and organ function within 14 days prior to initiation of study
treatment

- For women of childbearing potential: Must have a negative serum pregnancy test result
within 14 days prior to initiation of study treatment and agreement to remain
abstinent or use contraceptive measures

- For men: agreement to remain abstinent or use contraceptive measures, and agreement to
refrain from donating sperm

Exclusion Criteria

- Current participation or enrollment in another interventional clinical trial

- Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is
shorter) prior to start of study treatment

- Treatment with investigational therapy within 28 days prior to initiation of study
treatment

- Pregnant or breastfeeding, or intending to become pregnant during the study

- History of or concurrent serious medical condition or abnormality in clinical
laboratory tests that, in the investigator's judgment, precludes the patient's safe
participation in and completion of the study or confounds the ability to interpret
data from the study

- Severe infection within 4 weeks prior to initiation of study treatment or any active
infection that, in the opinion of the investigator, could impact patient safety

- Incomplete recovery from any surgery prior to the start of study treatment that would
interfere with the determination of safety or efficacy of study treatment

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures (once monthly or more frequently)

- Uncontrolled tumor-related pain

- Uncontrolled or symptomatic hypercalcemia

- Clinically significant and active liver disease

- Known HIV infection

- Symptomatic, untreated, or actively progressing CNS metastases

- History of leptomeningeal disease or carcinomatous meningitis

- History of malignancy other than CRC within 2 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death

- Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction,
physical examination finding, or clinical laboratory finding that contraindicates the
use of an investigational drug, may affect the interpretation of the results, or may
render the patient at high risk from treatment complications

- Requirement for treatment with any medicinal product that contraindicates the use of
any of the study treatments, may interfere with the planned treatment, affects patient
compliance, or puts the patient at higher risk for treatment-related complications

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

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact.

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Activated Prothrombin Complex Concentrate FEIBA to Optimize Postcardiopulomonary Bypass Hemostasis in Pediatric Cardiac Patients

A Study to Compare FEIBA to Alternative Blood Products in Treating Children After Cardiac Surgery

Elena Ashikhmina
All
up to 5 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-304831-H01-RST
21-005539
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Inclusion Criteria:

  • Weight ≤ 15 kg.
  • Elective cardiac surgery with cardiopulmonary bypass.
  • Coagulopathic bleeding after cardiopulmonary bypass.
  • Availability and willingness of the parent/legal guardian to provide informed consent.


Exclusion Criteria:

  • Presence of mechanical circulatory support at the time of randomization or POD 0 and 1.
  • Patient or family history of coagulopathy and/or thromboses.
  • Preoperative anticoagulation (excluding low dose heparin for “line prophylaxis”).
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Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy

A Study to Evaluate Mesenchymal Stem Cells to Treat Multiple System Atrophy

Wolfgang Singer
All
30 years to 70 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-304839-H01-RST
21-005569
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  1.  

Inclusion Criteria:

  • Males or females aged 30-70 years, who are willing and able to give informed consent.
  • Clinical diagnosis of MSA, fulfillin,g consensus criteria for probable MSA.
  • UMSARS I (omitting question 11) between 5 and 17, and able to walk unaided (i.e. abl,e to walk at least 50 yards without the use of a cane or walker, and without other support such as holding on to an arm or touching walls).
  • Anticipated survival of at least 3 years in the opinion of the investigator.
  • Normal cognition as assessed by the Montreal Cognitive Assessment (MOCA).  We will require a value ≥ 26.


Exclusion Criteria:

  • Pregnant or breastfeeding women, and women of childbearing potential who do not agree to practice an acceptable method of birth control. Acceptable methods of birth control in this study are: surgical sterilization, intrauterine devices, partner’s vasectomy, a double-protection method (condom or diaphragm with spermicide), hormonal contraceptive drug (i.e., oral contraceptive, contraceptive patch, long-acting injectable contraceptive) with a required second mode of contraception. 
  • Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the study or might affect study results. These include conditions causing significant CNS or autonomic dysfunction, clinically significant peripheral neuropathy, active malignant neoplasm, amyloidosis, active autoimmune disease, immunocompromised state, active infection, congestive heart failure (NYHA III or IV), recent (< 6 months) myocardial infarction, history of stoke with residual deficits, uncontrolled diabetes mellitus, alcoholism,  orthopedic problems that compromise mobility and activity of daily living, significant liver or kidney disease, thrombocytopenia (< 50 x 10^9/L), disorders affecting coagulation, and patients on active anticoagulation.
  • Participants who have taken any investigational products within 90 days prior to baseline, or with expected effects lasting beyond 60 days prior to baseline.
  • Medications that could affect clinical evaluations are permitted but need to be withdrawn at least four half-lives prior to study visits. Those include medications used to treat motor symptoms, such as levodopa and other anti-Parkinsonian medications.
  • Patients with contraindication to any of the study procedures, in particular MRI scanning.
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ALLO-605-201, A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (ALLO-605-201)

Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

Shaji Kumar
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-304858-P01-RST
21-006335
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Inclusion Criteria:


- Documented diagnosis of relapsed/refractory multiple myeloma (MM)

- Subjects must have measurable disease

- Subjects must have received ≥ 3 prior MM lines of therapy

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate hematologic, renal, liver, pulmonary, and cardiac functions

- Life expectancy of at least 3 months without treatment


Exclusion Criteria:


- Subjects with known active or history of central nervous system (CNS) or
leptomeningeal involvement of myeloma or plasma cell leukemia

- Current or history of thyroid disorder (including hyperthyroidism), except for
subjects with hypothyroidism controlled on a stable dose of hormone replacement
therapy

- Autologous stem cell transplantation within last 6 weeks prior to the start of
lymphodepletion

- Any prior allogeneic hematopoietic stem cell transplantation

- Systemic anti-cancer therapy within 2 weeks prior to the start of lymphodepletion

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A Phase 2 Open-Label Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Nedosiran in Pediatric Patients from Birth to 11 Years of Age with Primary Hyperoxaluria and Relatively Intact Renal Function (PHYOX8)

A Study to Evaluate the Safety, Tolerability and Effectiveness of Nedosiran in Pediatric Patients with Primary Hyperoxaluria and Relatively Intact Renal Function

David Sas
All
up to 11 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-304881-P01-RST
21-005579
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Inclusion Criteria:

  • Birth to 11 years of age inclusive, at the time of signing the informed consent.
  • Documented diagnosis of PH1 or PH2 confirmed by genotyping (historically available genotype information is acceptable for study eligibility).
  • Average spot Uox to creatinine ratio at Screening above 2 times the 95th percentile for age (Matos et al, 1999):
    • > 0.44 mol/mol in participants < 6 months;
    • > 0.34 mol/mol in participants from 6 months to < 12 months;
    • > 0.26 mol/mol in participants 12 months to < 2 years;
    • > 0.20 mol/mol in participants from 2 to < 3 years; and
    • > 0.16 mol/mol in participants from 3 to 5 years.
  • Estimated GFR at Screening ≥ 30 mL/min normalized to 1.73 m^2 BSA. For infants aged less than 12 months, serum creatinine below the 97th percentile of a healthy population (Boer et al., 2010).
  • Participants must have been on a stable treatment regimen for PH for 3 months prior to Day 1 and parent(s)/legal guardian should be willing to ensure participant remains on the same stable treatment regimen during the study.
  • Body weight ≥ 10 kg.
  • Male or female.
  • Participant’s parent or legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day according to the SoA (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant using the rating scales during the scheduled study visits; accurately and reliably dispense study intervention as directed.
  • Affiliated with or is a beneficiary of a health insurance system (if applicable per national regulations).


Exclusion Criteria:

  • Prior renal or hepatic transplantation; or planned transplantation within the study period.
  • Currently receiving dialysis or anticipating requirement for dialysis during the study period.
  • Plasma oxalate (Pox) > 30 μmol/L at Screening.
  • Documented evidence of clinical manifestations of severe systemic oxalosis (including preexisting retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations).
  • Presence of any condition or comorbidities that would interfere with study compliance or data interpretation or potentially impact participant’s safety including, but not restricted to:
    • Severe intercurrent illness;
    • Known causes of active liver disease/injury or transaminase elevation (e.g., alcoholic liver disease, nonalcoholic fatty liver disease/steatohepatitis [NAFLD/NASH]);
    • History of serious mental illness that includes, but is not limited to, schizophrenia, bipolar disorder, or severe depression requiring hospitalization or pharmacological intervention;
    • Clinically relevant history or presence of cardiovascular, respiratory, gastrointestinal, hematological, lymphatic, neurological, musculoskeletal, genitourinary, immunological diseases, including dermatological including rash, severe eczema or dermatitis, or connective tissue diseases or disorders.
  • Use of an RNAi drug within the last 6 months.
  • History of 1 or more of the following reactions to an oligonucleotide-based therapy:
    • Severe thrombocytopenia (platelet count ≤ 100,000/μL);
    • Hepatotoxicity, defined as ALT or AST > 3 times the upper ULN and total bilirubin > 2 × ULN or INR > 1.5;
    • Severe flu-like symptoms leading to discontinuation of therapy;
    • Localized skin reaction from the injection (graded severe) leading to discontinuation of therapy;
    • Coagulopathy/clinically significant prolongation of clotting time.
  • Participation in any clinical study in which they received an IMP within 4 months or 5 times the half-life of the drug (whichever is longer) before Screening:
    • For IMPs with the potential to reduce urine and/or plasma oxalate concentrations, these concentrations must have returned to historical baseline levels prior to Screening.
  • Liver function test (LFT) abnormalities: ALT and/or AST > 1.5 × ULN for age and gender.
  • Known hypersensitivity to nedosiran, or any of its ingredients.
  • Inability or unwillingness to comply with the specified study procedures, including the lifestyle considerations.

Eligibility last updated 5/11/22. Questions regarding updates should be directed to the study team contact.

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Understanding How Cognitive Performance and Physiological Measures Change After Acute Stress and How Different Sensory Features of a Relaxation Room Help Recovery

A Study to Evaluate How Cognitive Performance and Physiological Measures Change After Acute Stress

Colin West
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-304922-H01-RST
21-005885
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Inclusion Criteria:

  • Adults at least age 18.
  • Participants are able to remain in the Well Living Lab for 3-4 hours.
  • Participants are able to perform scripted tasks.
  • Participants are able to provide informed consent
  • Participants are able to wear the wearable devices at all times during the study
  • Participants have completed a COVID vaccine regimen and can provide written documentation verifying vaccination status at least fourteen (14) days prior to the commencement of the research study.


Exclusion Criteria:

  • Participants with a reported history of diagnosed mood, anxiety, or major health disorders.
  • Participants who have used steroid-based medications within the past three years.
  • Participants with a history of drug/alcohol abuse.
  • Participants with or recovering from nicotine dependency who cannot use a nicotine patch.
  • Participants who consume excessive amounts of caffeine.
  • Participants who have had severe sleep disturbance (e.g., shift work, chronic insomnia).
  • Women who are pregnant or intend to become pregnant at the time of the study.
  • Participants with a history of diagnosed cognitive impairment.
  • Participants taking any medications that might affect the physiological measures of interest.
  • Participants with anything that might affect collecting the physiological measures of interest (e.g., cosmetic products, head coverings, head products, etc.).
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A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) Tablet in Adult Patients with Advanced Cholangiocarcinoma (TT420C1206)

A Study to Evaluate the Safety and Effectiveness of TT-00420 in Adults with Advanced Cholangiocarcinoma

Lionel Aurelien Kankeu Fonkoua
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304924-P01-RST
21-005915
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Inclusion Criteria:

  • ≥ 18 years of age, at the time of signing informed consent.
  • Histologically or cytologically documented advanced/metastatic or surgically unresectable cholangiocarcinoma who have received at least one line of prior systemic chemotherapy. Patients will be assigned to 1 of 4 cohorts:
    • Cohort A1: FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor;
    • Cohort A2: FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor;
    • Cohort B: other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions;
    • Cohort C: negative for FGFR alterations (FGFR wild-type).
  • At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors.
  • Documentation of FGFR gene alteration status.
  • ECOG performance status of 0 or 1.
  • Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by:
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 /L;
    • Hemoglobin (Hgb) ≥ 8 g/dl;
    • Platelets (plt) ≥ 75 x 10^9 /L;
    • AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present;
    • Total bilirubin ≤ 1.5 x ULN;
    • Calculated 24-hour clearance ≥ 50 mL/min (Cockcroft Gault formula).
  • Negative pregnancy test within 72 hours before starting study treatment in all premenopausal women and women < 12 months after the onset of menopause.
  • Must agree to take sufficient contraceptive methods to avoid pregnancy (including male and female participants) during the study and until at least 6 months after ceasing study treatment.
  • Able to sign informed consent and comply with the protocol.


Exclusion Criteria:

  • Women who are pregnant or lactating.
  • Women of child-bearing potential (WOCBP) who do not use adequate birth control.
  • Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g. evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases) Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment.
  • Patients with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy.
  • Patients with the following mood disorders as judged by the Investigator or a psychiatrist:
    • Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia; a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others);
    • ≥ CTCAE grade 3 anxiety.
  • Impaired cardiac function or significant diseases, including but not limited to any of the following:
    • LVEF < 45% as determined by MUGA scan or ECHO;
    • Congenital long QT syndrome;
    • QTcF ≥ 480 msec on screening ECG;
    • Unstable angina pectoris ≤ 3 months prior to starting study drug;
    • Acute myocardial infarction ≤ 3 months prior to starting study drug.
  • Patients with uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic at Screening).
  • Patients with:
    • unresolved diarrhea ≥ CTCAE grade 2; or
    • impairment of gastrointestinal (GI) function; or
    • GI disease that may significantly alter the absorption of TT-00420.
  • Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., uncontrolled hypertriglyceridemia [triglycerides > 500 mg/dL], or active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
  • Patients who have received chemotherapy, targeted therapy, or immunotherapy ≤ 5 half-lives or 3 weeks, whichever is shorter, (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug.
  • Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy.
  • Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy.
  • Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.
  • Patients who are currently receiving treatment with strong CYP3A inhibitors or inducers ≤ 2 weeks prior to starting study drug.
  • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory; patients with well controlled HIV might be enrolled per investigator’s discretion and Sponsor approval).
  • Evidence of active infection with Hepatitis B or Hepatitis C that is not adequately controlled. For patients with known prior history of Hepatitis B or Hepatitis C, enrollment may be allowed per investigator’s discretion and Sponsor approval.
  • Inability to swallow or tolerate oral medication.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient’s safe participation and compliance in the trial.

 

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COllaborative, National QUality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients (CONQUER) (CONQUER)

A Registry to Track Scleroderma Progression

Ashima Makol
All
18 years and over
This study is NOT accepting healthy volunteers
2021-304932-P01-RST
21-005952
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Inclusion Criteria:

  • Patients 18 and older, inclusive; AND
  • Patients who meet the 2013 ACR/EULAR classification criteria for systemic sclerosis; AND
  • < 5 years from onset of first non-RP symptom attributed to systemic sclerosis.


Exclusion Criteria:

  • Patients under 18 years of age.
  • Patients with cognitive impairment that will interfere with conducting the study. Study staff should determine if the patient, at that moment, has the cognitive capacity to understand what the study entails, assent to participate, and complete the assessments. If there is question as to whether a patient may meet this criterion, RCs/RAs should defer to the site PI trained on the study to help determine; OR
  • Patients who are non-English Speaking. The patient must be able to proficiently read, speak, and understand English in order to be eligible.
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Mayo Clinic — Rochester, MN

The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Trial (PABST-BR)

A Study to Evaluate Practical Anemia Bundle for SusTained Blood Recovery

Matthew Warner
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-304949-H01-RST
21-006511
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Inclusion Criteria:


- Provision of signed and dated informed consent form (may be completed by legal proxies
for those patients unable to provide consent, i.e. sedation/intubation)

- Stated willingness to comply with all study procedures and availability for the
duration of the study, including follow-up assessments

- Current ICU admission at Mayo Clinic Rochester with anticipated ICU duration >48 hours
after enrollment

- Current ICU duration < 7 days

- Patients embedded in the local or regional Mayo Clinic Health System to facilitate
post-hospitalization outcome assessment

- Moderate-to-severe anemia (i.e. hemoglobin concentration < 10 g/dL) at the time of
enrollment, with the hemoglobin concentration assessed no more than 24 hours prior to
enrollment. If RBC transfusion has been administered between the qualifying hemoglobin
assessment and enrollment, a repeat hemoglobin will be required prior to enrollment to
ensure that it remains < 10 g/dL.


Exclusion Criteria:


- Recent or current iron or erythropoiesis stimulating agent (ESA) use (i.e.
darbepoetin, Aranesp, erythropoietin, Epogen, Procrit, Retacrit) within 30 days of
enrollment, exclusive of oral iron for general nutritional support (e.g. multivitamin
with iron)

- Severe anemia prior to hospitalization (i.e. hemoglobin <9 g/dL within 90 days of
admission)

- Known allergic reactions to iron or EPO

- Inability to complete outcome assessments (i.e. not expected to survive
hospitalization, unable to make follow-up appointments, non-ambulatory, dementia or
other severe cognitive impairment, visual impairment i.e. blind or legally blind)

- Pregnancy or breastfeeding at time of enrollment

- Inability to receive pharmacologic venous thromboembolic prophylaxis except in
patients with recent surgical or gastrointestinal bleeding

- Active or suspected thrombosis (i.e. deep venous thrombosis, pulmonary embolism, acute
arterial thrombus within 3 months)

- Uncontrolled sepsis (i.e. <48 hours of appropriate antimicrobial therapy and/or lack
of definitive source control)

- Having received ≥10 units of allogeneic RBCs in the 48 hours before enrollment

- Acute coronary syndrome or ischemic stroke within 3 months

- Weight less than 40 kg

- Concerns with study enrollment expressed by the clinical team

- Mechanical circulatory support devices

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

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (CLP05)

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Geoffrey Johnson
Male
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-304957-P01-RST
21-006009
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Inclusion Criteria:

  • Signed informed consent.
  • ≥ 18 years of age.
  • Eastern Cooperative Oncology Group performance status of 0 to 2.
  • Life expectancy > 6 months;.
  • Histological, pathological, and/or cytological confirmation of PCa.
  • Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SARbisPSMA uptake (standardized uptake value [SUV] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan.
    • NOTE: ALL OTHER ELIGIBILITY CRITERIA MUST BE FULFILLED BEFORE THE 64Cu-SAR-bisPSMA ADMINISTRATION IS PERMITTED. THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE DOSIMETRY PHASE;
  • Castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
  • Have progressive mCRPC despite prior androgen deprivation therapy and at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria:
    • Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL;
    • Soft-tissue progression defined as a ≥ 20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD  since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;
    • Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.
  • ≥ 1 metastatic lesion that is present at screening CT, magnetic resonance imaging (MRI), or bone scan imaging obtained ≤ 28 days prior to enrollment into the study.
  • Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.).
  • Participants must have adequate organ function:
  • Bone marrow reserve:
    • White blood cell (WBC) count ≥ 2.5 x 10⁹/L (2.5 x 109/L is equivalent to 2.5 x 10³/μL and 2.5 x K/μL and 2.5 x 10³/cc and 2500/μL); OR
    • Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L (1.5 x 10⁹/L is equivalent to 1.5 x 10³/μL and 1.5 x K/μL and 1.5 x 10³/cc and 1500/μL);
  • Platelets ≥ 100 x 10⁹/L (100 x 10⁹/L is equivalent to 100 x 10³/μL and 100 x K/μL and 100 x 10³/cc and 100,000/μL);
  • Hemoglobin ≥ 9 g/dL (5.59 mmol/L);
  • Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted;
  • Alanine aminotransferase or aspartate aminotransferase ≤ 3.0 x ULN OR ≤ 5.0 x ULN for participants with liver metastases;
  • Creatinine clearance or estimated glomerular filtration rate ≥ 50 mL/min.;
  • For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator;
  • For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.


Exclusion Criteria:

  • Major surgery within 12 weeks prior to enrollment into the study.
  • Brain metastasis.
  • Histologic  diagnosis  of  small  cell  or  neuroendocrine  prostate cancer.
  • Prior history of leukemia or Myelodysplastic Syndrome.
  • Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study.
  • Unmanageable urinary tract obstruction.
  • Evidence of progressive lesion(s) on MRI and/or CT (> 1 cm in mean   diameter) that is prostate-specific   membrane   antigen (PSMA)  negative  on  the  1  hour  ⁶⁴Cu-SAR-bisPSMA  PET/CT scan  as  determined  at  screening.
    • NOTE:  THIS  CRITERION  IS NOT APPLICABLE TO PARTICIPANTS IN THE DOSIMETRY AND DOSE ESCALATION PHASE.
  • Previous  treatment  with  any  systemic  radionuclide  (e.g.,  Lu, Strontium-89,   Samarium-153,    Rhenium-186,    Rhenium-188, Actinium-225,  Radium-223,  Iodine-131)  within  6 months  of treatment initiation;
  • Previous  treatment  with  any  systemic  anti-cancer  therapy  (e.g., chemotherapy, immunotherapy  or  biological  therapy  [including monoclonal  antibodies])  within  4  weeks prior  to  treatment  on study  with  the  exception  of  Luteinizing  Hormone  Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is  discontinued  prior  to  enrolment,  14  days  must  elapse after abiraterone discontinuation and 28 days after enzalutamide before participant can be enrolled) or low dose corticosteroids.
    • NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE DOSIMETRY PHASE.
  • Previous treatment with any investigational agents within 4 weeks prior enrollment into the study.
  • Known hypersensitivity to the components of the investigational products or its analogues.
  • Transfusion for the sole purpose of making a participant eligible for study inclusion.
  • Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  • Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, 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.
  • 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 for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer.
  • Any condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or carer at the time of release following the completion of therapy (e.g., uncontrolled urinary incontinence, high dependency care).
  • Participants in whom it is known that EBRT is scheduled after enrollment into the study.
    • NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE DOSIMETRY PHASE.
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Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing – Ascertaining Serial Cancer Patients to Enable New Diagnostic II (DETECT-ASCEND 2) (ASCEND 2)

A Study to Detect Cancers Through Elective Plasma-based CancerSEEK Testing

Amrit Singh
All
50 years and over
This study is NOT accepting healthy volunteers
2021-304965-P01-MAIJ
21-006028
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Inclusion Criteria
•All Subjects:

  • ≥ 50 years of age
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information or personal data to the study investigator.

Inclusion Criteria
•Cancer Subjects Only:

  • Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian, esophageal cancer, head and neck squamous cell, thyroid, small intestine, cervical, anal, vulva, or testis confirmed through pathology reports and/or clinical/radiographic data; or
  • Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.


Exclusion Criteria:

  • Prior or concurrent cancer diagnosis defined as:
    • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
    • Recurrence of the same primary cancer within any timeframe; OR
    • Concurrent diagnosis of multiple primary cancers.
  • Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
  • Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
  • Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
  • Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
  • IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
  • Individual has a condition the Investigator believes would interfere with the subject’s ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
  • Participant has an active febrile infection prior to blood draw.
  • History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Mankato, MN

Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing – Ascertaining Serial Cancer Patients to Enable New Diagnostic II (DETECT-ASCEND 2) (ASCEND 2)

A Study to Detect Cancers Through Elective Plasma-based CancerSEEK Testing

Mina Hanna
All
50 years and over
This study is NOT accepting healthy volunteers
2021-304965-P01-ALCL
21-006028
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Inclusion Criteria
•All Subjects:

  • ≥ 50 years of age
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information or personal data to the study investigator.

Inclusion Criteria
•Cancer Subjects Only:

  • Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian, esophageal cancer, head and neck squamous cell, thyroid, small intestine, cervical, anal, vulva, or testis confirmed through pathology reports and/or clinical/radiographic data; or
  • Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.


Exclusion Criteria:

  • Prior or concurrent cancer diagnosis defined as:
    • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
    • Recurrence of the same primary cancer within any timeframe; OR
    • Concurrent diagnosis of multiple primary cancers.
  • Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
  • Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
  • Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
  • Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
  • IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
  • Individual has a condition the Investigator believes would interfere with the subject’s ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
  • Participant has an active febrile infection prior to blood draw.
  • History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Albert Lea, MN

Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing – Ascertaining Serial Cancer Patients to Enable New Diagnostic II (DETECT-ASCEND 2) (ASCEND 2)

A Study to Detect Cancers Through Elective Plasma-based CancerSEEK Testing

John Kisiel
All
50 years and over
This study is NOT accepting healthy volunteers
2021-304965-P01-RST
21-006028
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Inclusion Criteria
•All Subjects:

  • ≥ 50 years of age
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information or personal data to the study investigator.

Inclusion Criteria
•Cancer Subjects Only:

  • Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian, esophageal cancer, head and neck squamous cell, thyroid, small intestine, cervical, anal, vulva, or testis confirmed through pathology reports and/or clinical/radiographic data; or
  • Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.


Exclusion Criteria:

  • Prior or concurrent cancer diagnosis defined as:
    • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
    • Recurrence of the same primary cancer within any timeframe; OR
    • Concurrent diagnosis of multiple primary cancers.
  • Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
  • Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
  • Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
  • Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
  • IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
  • Individual has a condition the Investigator believes would interfere with the subject’s ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
  • Participant has an active febrile infection prior to blood draw.
  • History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

(ECTx) A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients with Advanced Solid Tumors Harboring KRAS G12C Mutation

JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

Konstantinos Leventakos
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-304988-P01-RST
21-006138
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Inclusion Criteria:


- Participants must be able to provide an archived tumor sample

- Histologically or cytologically confirmed solid tumors with KRAS G12C mutation

- Must have received at least 1 prior standard therapy

- Must have at least 1 measurable lesion per RECIST v1.1

- Must have adequate organ function

- Must be able to swallow and retain orally administered medication


Exclusion Criteria:


- Has brain or spinal metastases, except if treated and no evidence of radiographic
progression or hemorrhage for at least 28 days

- Active infection requiring systemic treatment within 7 days

- Active HBV or HCV

- Any severe and/or uncontrolled medical conditions

- LVEF ≤50% assessed by ECHO or QTcF

- QT interval >470 msec

- Experiencing unresolved CTCAE 5.0 Grade >1 toxicities

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

Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.

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A Comparison of Muscle Versus Nerve-Based Surgical Procedures for Spastic Elbow Deformities: A Pilot Study (MTLvsHSN)

Management of Spastic Elbow Deformities

Peter Rhee
All
18 years and over
ERROR
This study is NOT accepting healthy volunteers
2021-304996-H01-RST
21-006151
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Inclusion Criteria:

  • Inclusion criteria consists of patients (≥ 18 years old) with predominant spasticity (MAS ≥ 2) in their elbow flexors without a severely fixed joint contracture (≤ 30 degrees of flexion deformity) as a result of an acquired brain injury (cerebrovascular accident, anoxic brain injury, traumatic brain injury).
  • Adult patients (≥ 18 years) who are at least 12 months from their neurologic insult without evidence of ongoing neurorecovery will be placed into the muscle-tendon lengthening versus HSN group.  Patients will be randomized to either study group with 16 patients in each cohort.   


Exclusion Criteria:
 

  • Patients < 18 years of age.
  • Patients who are not medically optimized to undergo surgery.
  • Patients who cannot participate in the pre-operative electrophysiologic and gait analysis.
  • Patients who are on chronic anticoagulation that cannot be held perioperatively.

Eligibility last updated 11/12/21. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery
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The electronic Medical Records and GEnomics (eMERGE) Network Genomic Risk Assessment (eMERGE IV)

A Network Genomic Risk Assessment of the Electronic Medical Records and Genomics

Iftikhar Kullo
All
3 years to 75 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-305003-P01-RST
21-006195
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Inclusion Criteria:

  • Adults, 18-75 years of age.
  • Children 3 to < 18 years of age.
  • Able to read or understand English or Spanish.
  • Able to provide a healthcare provider or clinician to receive results.
  • Willing to accept GIRA report.


Exclusion Criteria:

  • Inability to provide consent.
  • Transplant (solid organ or bone marrow) or transfusion within 8 weeks.
  • Research staff and investigators in eMERGE.
  • Unable to provide a HCP to receive results.
  • Not a patient at parent institution.
Diagnostic Test, Genetic
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Mayo Clinic — Rochester, MN

Correlation of Spinopelvic Movement with Lateral Radiographs to Assess Spine Motion Prior to Total Hip Arthroplasty

Correlation of Spinopelvic Movement with Lateral Radiographs to Assess Spine Motion Prior to Total Hip Arthroplasty

Rafael Sierra
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305013-H01-RST
21-006428
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Inclusion Criteria:


- Ability to provide informed consent.

- Hip pathology: 20 presenting for total hip arthroplasty, 20 presenting for joint
preservation procedures.


Exclusion Criteria:


- Patients with lumbosacral hardware, contralateral THA, or DJD in the contralateral hip.

Eligibility last updated 6/21/22. Questions regarding updates should be directed to the study team contact.

 

Device
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Mayo Clinic — Rochester, MN

Feasibility of the Automated Platelet Aggregation System PlateletWorks® in Cardiac Surgery Patients

A Study to Evaluate Automated Platelet Function Test in Cardiac Surgery Patients

Elena Ashikhmina
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305021-H01-RST
21-005216
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Elective cardiac surgery with cardiopulmonary bypass.
  • Informed consent on file.


Exclusion Criteria:
.

  • Presence of mechanical circulatory support.
  • Transfusion of blood products before initiation of cardiopulmonary bypass (CPB).
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Mayo Clinic — Rochester, MN

Rapid dEtection of HyperkAlemia (K+) in the EmergenCy Department Using a SmarTphone-enabled Single-lead EKG (REACT) (REACT)

A Study to Detect Hyperkalemia Using Smartphone-enabled EKG

John Dillon
All
50 years to 89 years old
This study is NOT accepting healthy volunteers
2021-305023-H01-RST
21-006298
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Inclusion Criteria:

  • Age greater than/equal to 50 years and able to provide consent.
  • Patients with eGFR (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 mEq/l.


Exclusion Criteria:

  • Patients underage < 50.
  • Do not meet inclusion criteria.
  • Unstable patients requiring emergent resuscitation.
  • Patients unable to provide consent.
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Mayo Clinic — Rochester, MN

AL-DES-01; RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients With Progressing Desmoid Tumors (RINGSIDE)

A Study to Evaluate AL102 to Treat Patients with Progressing Desmoid Tumors

Scott Okuno
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2021-305026-P01-RST
21-006448
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Inclusion Criteria
•Part A:

  • At least 18 years of age (inclusive) at the time of signing the ICF.
  • Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent) that has progressed by ≥ 20% as measured by RECIST v1.1 within 12 months of the screening visit scan.
  • At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part A only).
  • One of the following:
    • Treatment naïve subjects whose disease is not amenable to surgery without the risk of significant morbidity; OR
    • Recurrent/refractory disease following at least one line of therapy (including surgery, radiation, or systemic therapy).
  • A desmoid tumor in which continued progressive disease will not result in immediate significant risk to the subject.
  • Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for re-confirmation of disease.
  • Must be able to swallow whole capsules with no GI condition affecting absorption; nasogastric or G-tube administration is not allowed.

Exclusion Criteria
•Part A:

  • Diagnosed with a malignancy in the past 2 years.
  • Current or recent (within 2 months of IP administration) GI disease or disorders that increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
  • Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of IP such as known active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at Screening.
  • Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, , symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic evidence of acute ischemia.
  • Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the subject associated with his or her participation in the study.
  • Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
  • Abnormal organ and marrow function at Screening defined as:
    • Neutrophils < 1000/mm^3;
    • Platelet count < 100,000/mm^3;
    • Hemoglobin < 9 g/dL;
    • Total bilirubin > 1.5 x upper limit of normal (ULN) (except known Gilbert's syndrome);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x ULN;
    • Serum creatinine > ULN and creatinine clearance (CrCl) < 60 mL/min (calculation of CrCl will be based on acceptable institution standard).
  • Uncontrolled triglyceride ≥ Grade 2 elevations per common terminology criteria for adverse events (CTCAE) v5.0 (> 300 mg/dL or > 3.42 mmol/L).

ECG Exclusions (Part A only):

  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 450 mse.
  • QRS duration > 110 ms.
  • PR interval > 240 ms.
  • Marked ST-T wave abnormalities which would make it difficult to measure the QT interval.
  • Any treatments for desmoid tumors within 4 weeks prior to first dose of investigational therapy; subject must have recovered from therapy related toxicity to < CTCAE Grade 2 or clinical baseline. Therapy includes:
    • Locoregional tumor directed therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery;
    • Systemic therapy including chemotherapy, biologic (anti-neoplastic agent, antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or investigational therapy.
  • Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP.

Inclusion Criteria
•Part B:

  • ≥ 12 years of age (inclusive) and ≥ 40 kg at the time of signing the ICF.
  • Evidence of measurable disease by CT/MRI scan. Measurable lesions are defined according to RECIST v1.1.
  • Subject and/or legally authorized representative (i.e., parent/guardian) must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.
  • Minor subjects must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements).
  • For all other inclusion criteria refer to Part A inclusion criteria.

Exclusion Criteria
•Part B:

  • The subjects must be excluded from participating in the study if they meet any of the exclusion criteria for Part A, except where otherwise noted.
Drug, Other
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DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study) (DELFI-L101)

A Study to Evaluate DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study

Dennis Wigle
All
50 years and over
This study is NOT accepting healthy volunteers
2021-305030-P01-RST
21-006327
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Inclusion Criteria:


All Subjects:

1. Ability to understand and provide written informed consent

2. Age ≥ 50 years

3. Current or Former Smoker

4. ≥ 20 pack-years (pack years = number of packs per day X number of years smoked)

Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:

5. Prior thoracic imaging (computed tomography (CT)) within 12 months of enrollment OR
Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment

AND

6. Meet one of the criteria below:

1. No suspected or confirmed lung cancer diagnosis OR

2. Suspected of lung cancer OR

3. Confirmed, untreated lung cancer

Inclusion Group 2: High Risk Patients with cancer other than lung cancer that meet the
following criteria:

7. Pathologic confirmed, invasive cancer diagnosis, that is not lung cancer with no prior
systemic therapy, definitive therapy, radiation, or surgical resection.


Exclusion Criteria:


All Subjects:

1. Prior systemic therapy, definitive therapy, radiation, or surgical resection for
cancer within one year prior to enrollment (with the exception of organ biopsies or
surgery for non-melanoma skin cancer)

2. Any history of hematologic malignancies or myelodysplasia

3. Any history of organ tissue transplantation

4. Any history of blood product transfusion

5. Current pregnancy

6. Any condition that in the opinion of the Investigator should preclude the subject's
participation in the study

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

Eligibility last updated 11/16/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

A Pilot Study to Compare Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans with Spinal Cord Injury

Service Line TransPerc

Kristin Zhao
All
22 years and over
Not Applicable, Early Feasibility
This study is NOT accepting healthy volunteers
2021-305038-H01-RST
21-006340
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Inclusion Criteria:


- Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae
(T10)

- American Spinal Injury Association grading scale of A-D (2 from each) below the level
of SCI

- Intact spinal reflexes below the level of SCI

- At least 1-year post-SCI

- At least 22 years of age

- Willing to use medically acceptable methods of contraception, if female and of
child-bearing potential


Exclusion Criteria:


- Currently a prison inmate, or awaiting trial, related to criminal activity

- Pregnancy at the time of enrollment

- History of chronic and/or treatment resistant urinary tract infection

- Unhealed decubitus ulcer

- Unhealed skeletal fracture

- Untreated clinical diagnosis of depression

- Undergoing, or planning to undergo, diathermy treatment

- Active participation in another interventional clinical trial

- Presence of conditions or disorders which require MRI monitoring

- A history of coagulopathy or other significant cardiac or medical risk factors for
surgery

- Current use of a ventilator

- Clinically diagnosed cardiopulmonary complications such as chronic obstructive
pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in
body position such as supine-to-sit-to-stand activities, prolonged standing, or
stepping

- History of frequent hypotension characterized by light headedness, or loss of
consciousness

- History of frequent hypertension characterized by headache, or bradycardia

- History of frequent, severe, autonomic dysreflexia

- Any illness or condition which, based on the research team's assessment, will
compromise with the patient's ability to comply with the protocol, patient safety, or
the validity of the data collected during this study.

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

Eligibility last updated 12/20/22. Questions regarding updates should be directed to the study team contact.

Device
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Aortic, Peripheral & Venous (APV) Product Surveillance Registry Platform Base Clinical Investigation

Product Surveillance Registry-APV

Sanjay Misra
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305072-P01-RST
21-006635
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Inclusion Criteria:

  • Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
  • Patient has, or is intended to receive or be treated with, an eligible Medtronic product.
  • Patient is consented within the enrollment window of the therapy received, as applicable.


Exclusion Criteria:

  • Patient who is, or is expected to be, inaccessible for follow-up.
  • Patient is excluded by local law.
  • Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness).

 

 

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Mayo Clinic — Rochester, MN

Research for Individualized Therapeutics in Rare Genetic Disease

Individualized Therapeutics in Rare Genetic Disease

Brendan Lanpher
All
Not specified
This study is NOT accepting healthy volunteers
2021-305076-H01-RST
21-006562
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Inclusion Criteria:

  • Has Mayo Clinic or other medical health system ID, or another unique identifier.
  • Able to provide informed consent.
  • Individual must have evidence of a genetic disorder as determined by a provider or genetic counselor with causative or likely causative genetic variants identified by molecular testing.
  • Genetic variants must be hypothesized to be targetable using antisense oligonucleotide drugs (such as: knockdown gain of function alterations, increase protein production for reduced function alterations, or modulate mRNA splicing to correct abnormal splicing, promote normal splicing, or return reading frame to an out-of-frame transcript to restore function, etc.) based on current acceptable understanding of ASO mechanisms of action and tissue/organ targeting efficiency.
  • Biological family member of an enrolled individual.
  • Would be able to travel to a Mayo Clinic site for ongoing treatment should a therapeutic be developed.
  • Treatment at the individual’s current disease state would likely provide benefit based on current clinical data and understanding of the progression of the disease.

 Exclusion Criteria

  • Individuals who have situations that would limit compliance with the study requirements.
  • Institutionalized (i.e., Federal Medical Prison).
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Oropharynx (OPX) Salivary Biomarker Study: Microbiome, Virome, and Metabolomics

OPX Saliva Biomarker Study

Kathryn Van Abel
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305082-H01-RST
21-006529
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Inclusion Criteria:

  • Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).
  • Normal Controls:
    • Age ≥ 18 years;
    • Able to provide informed written consent documenting permission to give saliva sample for research testing;
    • Ability to complete questionnaire(s) by themselves or with assistance.


Exclusion Criteria:
 

  • Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).
  • Normal Controls:
    • Any personal history of head or neck cancer including head or neck skin cancer;
    • Other active malignancy ≤ 5 years prior to registration. 
    • EXCEPTIONS:  Non-melanotic skin cancer, non-metastatic prostate cancer. 
    • NOTE:  If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
    • Dry mouth (xerostomia) caused by any chronic (> 30 days) condition (known or unknown) or medication;
    • Recent (within 30 days) or active upper aerodigestive tract or anogenital infections.
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