Malignant Neoplasm
Conditions
Keywords
PE-CGS, Southwestern Tribal Nations, Cancer Genome Sequencing, American Indians
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: 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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of tissue, blood, saliva, and stool samples
PROCEDUREReturn of Results
Receive results
OTHERSurvey Administration
Surveys and Interviews
Sponsors
National Cancer Institute (NCI)
New Mexico Cancer Research Alliance
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Enrolled Participants | Up to 18 months | Number and percent of eligible participants enrolled and consented |
| Data participation rate | 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 |
| Biospecimen participation rate | Up to 18 months | Number and percent of enrolled participants for whom biospecimens are collected and processed for genomic analysis |
| Rate of comprehensive genomic analysis completion | Up to 18 months | Number and percent of participants/samples that undergo successful comprehensive genomic and bioinformatic analysis |
| Rate of successful return of clinical genetic/genomic results | Up to 18 months | Number and percent of participants who elect to receive clinical genetic/genomic results and incidental findings |
| Rate of new threptic intervention as a result of participation | Up to 18 months | Number and percent of participants/patients whose clinical genomic data facilitates therapeutic intervention |
| Rate of Preparatory and Optimization Phase completion | Up to 18 months | Successful completion of the Preparatory and Optimization Phases |
Countries
United States
Contacts
Primary ContactAndrew Sussman, PhD
Backup ContactKelsey Ayers, BS
Outcome results
None listed