Participant Engagement - Cancer Genome Sequencing (PE-CGS) Research Center: Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,001
- Locations
- 2
- Primary Endpoint
- Data participation rate
Study Overview
Brief 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:
- Conduct direct participant engagement with cancer patients/survivors, community advisors, and partners to refine and optimize methods/processes;
- Identify, recruit and consent eligible AI cancer patients/survivors;
- Implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks;
- Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The PE-CGS Research Center is only recruiting and sequencing tumors for adult-onset cancers (patients and survivors) among the American Indian Tribes, Nations, and Pueblos of New Mexico and adjacent states
- •Male or female adults (18 years) or older
- •Cancer patient undergoing active treatment or a cancer survivor
- •Self-identify as American Indian
Exclusion Criteria
- •Cognitively impaired
- •Adults unable to consent for themselves
- •Individuals who are not yet adults
- •Prisoners
Outcomes
Primary Outcomes
Data participation rate
Time Frame: Up to 18 months
Number and percent of eligible participants who complete, or partially complete, baseline and follow up data collection of epidemiological assessments and follow up data collection of epidemiological assessments
Rate of successful return of clinical genetic/genomic results
Time Frame: Up to 18 months
Number and percent of participants who elect to receive clinical genetic/genomic results and incidental findings
Biospecimen participation rate
Time Frame: Up to 18 months
Number and percent of enrolled participants for whom biospecimens are collected and processed for genomic analysis
Rate of new threptic intervention as a result of participation
Time Frame: Up to 18 months
Number and percent of participants/patients whose clinical genomic data facilitates therapeutic intervention
Rate of Preparatory and Optimization Phase completion
Time Frame: Up to 18 months
Successful completion of the Preparatory and Optimization Phases
Rate of comprehensive genomic analysis completion
Time Frame: Up to 18 months
Number and percent of participants/samples that undergo successful comprehensive genomic and bioinformatic analysis
Total Enrolled Participants
Time Frame: Up to 18 months
Number and percent of eligible participants enrolled and consented
Secondary Outcomes
No secondary outcomes reported