Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing

Malignant Neoplasm Clinical Trial

— PE-CGS  

Official title:

Participant Engagement - Cancer Genome Sequencing (PE-CGS) Research Center: Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207864
• Other study ID #: INST 2108
• Secondary ID: NCI-2023-024625U
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: December 31, 2030

Study information

• Verified date: January 2024
• Source: New Mexico Cancer Care Alliance
• Contact: Ursa Brown-Glaberman, MD
• Phone: (505) 272-4946
• Email: UBrown-Glaberman[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1001
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of tissue, blood, saliva, and stool samples
• Return of Results
Receive results

Other:
• Survey Administration
Surveys and Interviews

Locations

Country	Name	City	State
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Enrolled Participants	Number and percent of eligible participants enrolled and consented	Up to 18 months
Primary	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
Primary	Biospecimen participation rate	Number and percent of enrolled participants for whom biospecimens are collected and processed for genomic analysis	Up to 18 months
Primary	Rate of comprehensive genomic analysis completion	Number and percent of participants/samples that undergo successful comprehensive genomic and bioinformatic analysis	Up to 18 months
Primary	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
Primary	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
Primary	Rate of Preparatory and Optimization Phase completion	Successful completion of the Preparatory and Optimization Phases	Up to 18 months