Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing
NCT ID: NCT06207864
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1001 participants
INTERVENTIONAL
2022-03-22
2030-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Category 1 (biospecimens, surveys, interviews)
Cancer 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.
Biospecimen Collection
Undergo collection of tissue, blood, saliva, and stool samples
Return of Results
Receive results
Survey Administration
Surveys and Interviews
Interventions
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Biospecimen Collection
Undergo collection of tissue, blood, saliva, and stool samples
Return of Results
Receive results
Survey Administration
Surveys and Interviews
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female adults (18 years) or older
* Cancer patient undergoing active treatment or a cancer survivor
* Self-identify as American Indian
Exclusion Criteria
* Adults unable to consent for themselves
* Individuals who are not yet adults
* Prisoners
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
New Mexico Cancer Research Alliance
OTHER
Responsible Party
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Principal Investigators
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Cheryl Willman, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico Comprehensive Cancer Center
Nicole Hamblet
Role: STUDY_DIRECTOR
University of New Mexico Comprehensive Cancer Center
Andrew Sussman, PhD
Role: STUDY_DIRECTOR
University of New Mexico Comprehensive Cancer Center
Locations
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University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Countries
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Central Contacts
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Facility Contacts
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Kelsey Ayers, BS
Role: primary
References
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Islami 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.
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.
Jemal 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.
Ryerson 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.
Nir 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.
Melkonian 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.
Li 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.
Hoffman 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.
Sauer 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.
Other Identifiers
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NCI-2023-02462
Identifier Type: OTHER
Identifier Source: secondary_id
INST 2108
Identifier Type: -
Identifier Source: org_study_id