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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-02462 | Other Identifier | NCI | |
| 5U2CCA252973 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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:
The specific objectives of the EUO are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Category 1 (biospecimens, surveys, interviews) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of tissue, blood, saliva, and stool samples |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Sussman, PhD | Contact | (505) 272-4077 | ASussman@salud.unm.edu | |
| Kelsey Ayers, BS | Contact | 1-833-795-0464 | KeAyers@salud.unm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cheryl Willman, MD | University of New Mexico Comprehensive Cancer Center | Principal Investigator |
| Nicole Hamblet | University of New Mexico Comprehensive Cancer Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Comprehensive Cancer Center | Recruiting | Albuquerque | New Mexico | 87102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24754660 | Background | 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. | |
| 28376154 | Background | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Return of Results | Procedure | Receive results |
|
| Survey Administration | Other | Surveys and Interviews |
|
| Up to 18 months |
| Andrew Sussman, PhD |
| University of New Mexico Comprehensive Cancer Center |
| Study Director |
| 28586094 | Background | 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. |
| 26959385 | Background | 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. |
| 22236535 | Background | 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. |
| 31575554 | Background | 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. |
| 24754655 | Background | 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. |
| 24527035 | Background | 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. |
| 28515109 | Background | 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. |