University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06207864
Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
The specific objectives of the EUO are to:
- 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;
- Determine AI cancer patients' and survivors' knowledge, attitudes, cultural beliefs, information needs, and communication preferences and practices regarding clinical genomics testing;
- Determine AI cancer patients' and survivors' perspectives on strategies to engage and recruit participants for clinical genomics testing.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Biospecimen Collection
ProcedureUndergo collection of tissue, blood, saliva, and stool samples
Other names: Biological Sample Collection, Specimen Collection
Return of Results
ProcedureReceive results
Survey Administration
OtherSurveys and Interviews
Primary outcomes
-
Total Enrolled Participants
Time frame: Up to 18 months
Number and percent of eligible participants enrolled and consented
-
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
-
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 comprehensive genomic analysis completion
Time frame: 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
Time frame: 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
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
Study contacts
Contact information is provided by the study sponsor or research team.
Andrew Sussman, PhD
CONTACT
Kelsey Ayers, BS
CONTACT
Sponsors and collaborators
Lead sponsor
New Mexico Cancer Research Alliance
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Participant Engagement - Cancer Genome Sequencing (PE-CGS) Research Center: Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing
Acronym: PE-CGS
Important dates
- Study start
- 2022
- Primary completion
- 2028
- Study completion
- 2030
- First posted
- Jan 17, 2024
- Registry last updated
- Nov 13, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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