Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing
PE-CGS
Participant Engagement - Cancer Genome Sequencing (PE-CGS) Research Center: Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing
3 other identifiers
interventional
1,001
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2022
CompletedFirst Submitted
Initial submission to the registry
January 5, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
November 13, 2025
May 1, 2025
6.8 years
January 5, 2024
November 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Total Enrolled Participants
Number and percent of eligible participants enrolled and consented
Up to 18 months
Data participation rate
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
Up to 18 months
Biospecimen participation rate
Number and percent of enrolled participants for whom biospecimens are collected and processed for genomic analysis
Up to 18 months
Rate of comprehensive genomic analysis completion
Number and percent of participants/samples that undergo successful comprehensive genomic and bioinformatic analysis
Up to 18 months
Rate of successful return of clinical genetic/genomic results
Number and percent of participants who elect to receive clinical genetic/genomic results and incidental findings
Up to 18 months
Rate of new threptic intervention as a result of participation
Number and percent of participants/patients whose clinical genomic data facilitates therapeutic intervention
Up to 18 months
Rate of Preparatory and Optimization Phase completion
Successful completion of the Preparatory and Optimization Phases
Up to 18 months
Study Arms (1)
Category 1 (biospecimens, surveys, interviews)
EXPERIMENTALCancer patients and survivors undergo collection of tissue, blood, saliva, and stool samples on study for genomic sequencing and microbiome analysis. Cancer patients and survivors also complete surveys and interviews on study pre and post intervention.
Interventions
Undergo collection of tissue, blood, saliva, and stool samples
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cognitively impaired
- Adults unable to consent for themselves
- Individuals who are not yet adults
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102, United States
Related Publications (9)
White MC, Espey DK, Swan J, Wiggins CL, Eheman C, Kaur JS. Disparities in cancer mortality and incidence among American Indians and Alaska Natives in the United States. Am J Public Health. 2014 Jun;104 Suppl 3(Suppl 3):S377-87. doi: 10.2105/AJPH.2013.301673. Epub 2014 Apr 22.
PMID: 24754660BACKGROUNDJemal A, Ward EM, Johnson CJ, Cronin KA, Ma J, Ryerson B, Mariotto A, Lake AJ, Wilson R, Sherman RL, Anderson RN, Henley SJ, Kohler BA, Penberthy L, Feuer EJ, Weir HK. Annual Report to the Nation on the Status of Cancer, 1975-2014, Featuring Survival. J Natl Cancer Inst. 2017 Sep 1;109(9):djx030. doi: 10.1093/jnci/djx030.
PMID: 28376154BACKGROUNDIslami F, Miller KD, Siegel RL, Fedewa SA, Ward EM, Jemal A. Disparities in liver cancer occurrence in the United States by race/ethnicity and state. CA Cancer J Clin. 2017 Jul 8;67(4):273-289. doi: 10.3322/caac.21402. Epub 2017 Jun 6.
PMID: 28586094BACKGROUNDRyerson AB, Eheman CR, Altekruse SF, Ward JW, Jemal A, Sherman RL, Henley SJ, Holtzman D, Lake A, Noone AM, Anderson RN, Ma J, Ly KN, Cronin KA, Penberthy L, Kohler BA. Annual Report to the Nation on the Status of Cancer, 1975-2012, featuring the increasing incidence of liver cancer. Cancer. 2016 May 1;122(9):1312-37. doi: 10.1002/cncr.29936. Epub 2016 Mar 9.
PMID: 26959385BACKGROUNDNir I, Wiggins CL, Morris K, Rajput A. Diversification and trends in biliary tree cancer among the three major ethnic groups in the state of New Mexico. Am J Surg. 2012 Mar;203(3):361-5; discussion 365. doi: 10.1016/j.amjsurg.2011.12.002. Epub 2012 Jan 10.
PMID: 22236535BACKGROUNDMelkonian SC, Jim MA, Haverkamp D, Wiggins CL, McCollum J, White MC, Kaur JS, Espey DK. Disparities in Cancer Incidence and Trends among American Indians and Alaska Natives in the United States, 2010-2015. Cancer Epidemiol Biomarkers Prev. 2019 Oct;28(10):1604-1611. doi: 10.1158/1055-9965.EPI-19-0288.
PMID: 31575554BACKGROUNDLi J, Weir HK, Jim MA, King SM, Wilson R, Master VA. Kidney cancer incidence and mortality among American Indians and Alaska Natives in the United States, 1990-2009. Am J Public Health. 2014 Jun;104 Suppl 3(Suppl 3):S396-403. doi: 10.2105/AJPH.2013.301616. Epub 2014 Apr 22.
PMID: 24754655BACKGROUNDHoffman RM, Espey DK, Rhyne RL, Gonzales M, Rajput A, Mishra SI, Stone SN, Wiggins CL. Colorectal cancer incidence and mortality disparities in new Mexico. J Cancer Epidemiol. 2014;2014:239619. doi: 10.1155/2014/239619. Epub 2014 Jan 2.
PMID: 24527035BACKGROUNDSauer AG, Siegel RL, Jemal A, Fedewa SA. Updated Review of Prevalence of Major Risk Factors and Use of Screening Tests for Cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2017 Aug;26(8):1192-1208. doi: 10.1158/1055-9965.EPI-17-0219. Epub 2017 May 17.
PMID: 28515109BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl Willman, MD
University of New Mexico Comprehensive Cancer Center
- STUDY DIRECTOR
Nicole Hamblet
University of New Mexico Comprehensive Cancer Center
- STUDY DIRECTOR
Andrew Sussman, PhD
University of New Mexico Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2024
First Posted
January 17, 2024
Study Start
March 22, 2022
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2030
Last Updated
November 13, 2025
Record last verified: 2025-05