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

January 30, 2024 updated by: New Mexico Cancer Care Alliance

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1001

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Biospecimen Collection
Undergo collection of tissue, blood, saliva, and stool samples
Other Names:
  • Biological Sample Collection
  • Specimen Collection
Procedure: Return of Results
Receive results
Other: Survey Administration
Surveys and Interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Enrolled Participants
Time Frame: Up to 18 months
Number and percent of eligible participants enrolled and consented
Up to 18 months
Data participation rate
Time Frame: Up to 18 months
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
Time Frame: Up to 18 months
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
Time Frame: Up to 18 months
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
Time Frame: Up to 18 months
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
Time Frame: Up to 18 months
Number and percent of participants/patients whose clinical genomic data facilitates therapeutic intervention
Up to 18 months
Rate of Preparatory and Optimization Phase completion
Time Frame: Up to 18 months
Successful completion of the Preparatory and Optimization Phases
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Mexico Cancer Care Alliance

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Cheryl Willman, MD, University of New Mexico Comprehensive Cancer Center
  • Study Director: Ursa Brown-Glaberman, MD, University of New Mexico Comprehensive Cancer Center
  • Study Director: Andrew Sussman, PhD, University of New Mexico Comprehensive Cancer Center
  • Study Director: Shiraz I Mishra, MCCS, PhD, University of New Mexico Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INST 2108
  • NCI-2023-02462 (Other Identifier: NCI)
  • 5U2CCA252973 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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