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Trial Title:
Genetic Testing for the Prevention of Cancer in Indigenous American Communities (JUNIPER Trial)
NCT ID:
NCT06569316
Condition:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood or saliva and leftover tissue sample collection
Arm group label:
Screening (blood, saliva, tissue collection, genetic testing)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Communication Intervention
Description:
Receive care plan recommendations
Arm group label:
Screening (blood, saliva, tissue collection, genetic testing)
Intervention type:
Other
Intervention name:
Genetic Testing
Description:
Undergo genetic testing
Arm group label:
Screening (blood, saliva, tissue collection, genetic testing)
Other name:
Genetic Analysis
Other name:
Genetic Examination
Other name:
Genetic Test
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Screening (blood, saliva, tissue collection, genetic testing)
Summary:
This clinical trial is studying the genetic changes in cells associated with different
types of cancer in Indigenous American (IA) populations in the Southwest to improve
cancer screening, precision prevention, and therapeutic intervention for individual in
these communities. IA tribes have much lower rates of cancer screening, have more limited
access to healthcare, are more often diagnosed at later stages of disease, and have the
poorest outcomes in all types of cancer when compared to any other racial and ethnic
group in the United States. Due to these significant cancer health disparities, IAs have
been understudied and little is known about the molecular characterization of tumors
arising in IAs. Undergoing genetic testing of tumors may improve cancer outcomes in IA
participants and communities.
Detailed description:
PRIMARY OBJECTIVES:
I. To develop culturally appropriate, respectful, trusted, and collaborative means to
engage and recruit Indigenous Americans (IAs) 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 IA 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.
SECONDARY OBJECTIVE:
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 Indigenous American participants and
communities.
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female adults >= 18 years of age
- Cancer patient undergoing active treatment or a cancer survivor
- Self-identify as Indigenous American
Exclusion Criteria:
- Unable to provide informed consent
- Individuals who are under 18 years of age
- Prisoners
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Jewel Samadder, MD
Email:
Principal Investigator
Start date:
September 30, 2024
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06569316
https://www.mayo.edu/research/clinical-trials
