NCT06207864

Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing

Participant Engagement - Cancer Genome Sequencing (PE-CGS) Research Center: Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,001 (estimated)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies engagement strategies for recruiting American Indians (AI) of Southwestern Tribal Nations for cancer genome sequencing. American Indians in the Southwest have higher rates of some types of cancer, such as cancers that arise in the liver, kidney, breast, and colon. American Indians with cancer may also live for less time than people from other population groups who have been treated for the same cancer. Damage to the cells of the body, acquired as people live, grow older, and are exposed to the environment, causes genetic changes in cells that can lead to cancer. This study may help researchers learn how these genetic changes in cells cause cancer and understand how and why cancer is arising in American Indians in the Southwest. This may help better prevent and treat cancer in the future.

Detailed description

PRIMARY OBJECTIVES: The overall objective of the PE-CGS Research Center is to develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit American Indians affected by cancer (newly diagnosed cancer patients, patients undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors. The clinical trial is embedded in the Patient Engagement Unit (PEU) jointly with the Engagement Optimization Unit (EOU) The specific objectives for the PEU are to: 1. Conduct direct participant engagement with cancer patients/survivors, community advisors, and partners to refine and optimize methods/processes; 2. Identify, recruit and consent eligible AI cancer patients/survivors; 3. Implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks; 4. Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select. The specific objectives of the EUO are to: 1. Finalize consenting process and informed consent by direct engagement of AI cancer patients, survivors, healthcare providers, genetic counselors, consenting staff, tribal and spiritual leaders and tribal governance; 2. Determine AI cancer patients' and survivors' knowledge, attitudes, cultural beliefs, information needs, and communication preferences and practices regarding clinical genomics testing; 3. Determine AI cancer patients' and survivors' perspectives on strategies to engage and recruit participants for clinical genomics testing.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of tissue, blood, saliva, and stool samples
PROCEDURE	Return of Results	Receive results
OTHER	Survey Administration	Surveys and Interviews

Timeline

• Start date: 2022-03-22
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2024-01-17
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States