Genetic Testing for the Prevention of Cancer in Indigenous American Communities (JUNIPER Trial)

NCT06569316 | Recruiting

• 4 other identifiers: 24-006285NCI-2024-06870MC240902U2CCA252973
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (2)

• Successful accrual of Indigenous American (IA) participants

  Assessed by the number of IA participants consented to study.

  Up to 5 years

• Return of valuable genetic results to participants

  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

Study Arms (1)

Screening (blood, saliva, tissue collection, genetic testing)

EXPERIMENTAL

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 on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.

Procedure: Biospecimen Collection; Other: Communication Intervention; Other: Genetic Testing; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood or saliva and leftover tissue sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Screening (blood, saliva, tissue collection, genetic testing)

Communication Intervention OTHER

Receive care plan recommendations

Screening (blood, saliva, tissue collection, genetic testing)

Genetic Testing OTHER

Undergo genetic testing

Also known as: Genetic Analysis, Genetic Examination, Genetic Test

Screening (blood, saliva, tissue collection, genetic testing)

Survey Administration OTHER

Ancillary studies

Screening (blood, saliva, tissue collection, genetic testing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults \>= 18 years of age
• Cancer patient undergoing active treatment or a cancer survivor
• Self-identify as Indigenous American

You may not qualify if:

• Unable to provide informed consent
• Individuals who are under 18 years of age
• Prisoners

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Specimen Handling; Genetic Testing

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Jewel Samadder, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)