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

Summary

This clinical trial is studying the genetic changes in cells associated with different types of cancer in American Indian (AI) populations in the Southwest to improve cancer screening, precision prevention, and therapeutic intervention for individual in these communities. AI 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, AIs have been understudied and little is known about the molecular characterization of tumors arising in AIs. Undergoing genetic testing of tumors may improve cancer outcomes in AI participants and communities.

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.

Eligibility Criteria

Interventions