Genetic Testing for the Prevention of Cancer in American Indian Communities (JUNIPER Trial)
Journey to Understanding - American Indian Peoples Engagement in Cancer Research Arizona (JUNIPER)
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. To develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit American Indians (AIs) affected by cancer (newly diagnosed cancer participants, participants undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors.
Ia. Conduct direct participant engagement with cancer participants/survivors, community advisors, and partners to refine and optimize methods/processes.
Ib. Identify, recruit, and consent eligible AI cancer participants/survivors. Ic. Implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks.
Id. Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select.
Ie. To further understand microbiome diversity alterations associated with tumor initiation, progression, and response to therapy.
SECONDARY OBJECTIVES:
I. Translate any discoveries to improved cancer screening, precision prevention, and therapeutic intervention that can be used to enhance cancer screening and precision prevention and improve cancer outcomes in American Indian participants and communities.
II. Determine if microbiome sequencing will elucidate compositions and diversity distinct to these understudied cohorts, and that these microbiome alterations will offer novel diagnostic and therapeutic avenues in these patients.
OUTLINE:
Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from standard of care (SOC) surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
After completion of study intervention, patients are followed up once a year up to 5 years from study registration.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Recruiting
- Mayo Clinic in Arizona
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Jewel Samadder, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female adults >= 18 years of age
- Cancer patient undergoing active treatment or a cancer survivor
- Self-identify as American Indian
Exclusion Criteria:
- Unable to provide informed consent
- Individuals who are under 18 years of age
- Prisoners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Screening (blood, saliva, tissue collection, genetic testing)
Patients undergo collection of blood or saliva samples on study for genetic testing.
Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study.
Patients receive the results of their genetic testing and are given resources for counseling and further care.
|
Ancillary studies
Undergo genetic testing
Other Names:
Receive care plan recommendations
Undergo blood or saliva, leftover tissue, and mouthwash saliva sample collection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return of valuable genetic results to participants
Time Frame: Up to 5 years
|
Assessed by the number of participants who receive genetic results.
Clinically useful genomic data will be returned to participants with navigation to counseling and clinical resources as warranted and as they select.
|
Up to 5 years
|
|
Successful accrual of American Indian (AI) participants
Time Frame: Up to 5 years
|
Assessed by the number of AI participants consented to study.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jewel Samadder, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC240902 (Mayo Clinic in Arizona)
- 24-006285 (Other Identifier: Mayo Clinic Institutional Review Board)
- U2CCA252973 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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