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Trial Title:
Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing
NCT ID:
NCT06207864
Condition:
Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
PE-CGS
Southwestern Tribal Nations
Cancer Genome Sequencing
American Indians
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of tissue, blood, saliva, and stool samples
Arm group label:
Category 1 (biospecimens, surveys, interviews)
Other name:
Biological Sample Collection
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Return of Results
Description:
Receive results
Arm group label:
Category 1 (biospecimens, surveys, interviews)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Surveys and Interviews
Arm group label:
Category 1 (biospecimens, surveys, interviews)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of New Mexico Comprehensive Cancer Center
Address:
City:
Albuquerque
Zip:
87102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelsey Ayers, BS
Phone:
505-272-5062
Email:
KeAyers@salud.unm.edu
Contact backup:
Last name:
Koby Blackwater
Email:
KBlackwater@salud.unm.edu
Start date:
March 22, 2022
Completion date:
December 31, 2030
Lead sponsor:
Agency:
New Mexico Cancer Care Alliance
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
New Mexico Cancer Care Alliance
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06207864
