Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno)

NCT ID: NCT06960798

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-05-02
• Study Completion Date: 2029-06-30

Brief Summary

The purpose of this study is to analyze tumor tissue samples from patients of Native American identity with prostate cancer. By examining these samples, researchers hope to understand how different genes in your tumor can influence treatment decisions, how your cancer progresses and the outcome of your cancer.

Detailed Description

This study aims to establish a comprehensive database of Native American (NA) patients diagnosed with prostate cancer (PC), focusing on an in-depth characterization of the genomic landscape. Archived tumor tissue collected at screening and peripheral blood samples obtained within the first year of enrollment will serve as the basis for comprehensive molecular analyses. Whole exome sequencing (WES) and whole transcriptome sequencing (RNA-seq) will be performed to characterize and delineate the genomic and transcriptomic landscape of the study cohort. The study will initially enroll participants at the Stephenson Cancer Center, with planned expansion to additional sites across Oklahoma and, subsequently, to other institutions across the United States. Oversight will be maintained by the Tribal Institutional Review Board and an independent Community Advisory Board to ensure cultural appropriateness, transparency, and sustained community engagement throughout the research process. The overarching objective is to generate insights that will inform the development of personalized treatment strategies in the future.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Native American Group

150 patients will be assigned in this group.

Bio-specimen Collection

Intervention Type: OTHER

Tissue samples will be taken from existing archived collections and sent for further analysis.

Blood Draw

Intervention Type: OTHER

Blood samples will be collected within the first year of enrollment.

Interventions

Bio-specimen Collection

Tissue samples will be taken from existing archived collections and sent for further analysis.

Intervention Type: OTHER

Blood Draw

Blood samples will be collected within the first year of enrollment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Written informed consent signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses.
• At least 18 years-of-age at the time of signature of the informed consent form (ICF).
• Patients who self-identify as Native American.
• Patients with a pathologically proven diagnosis of PC (any stage).
• Availability of most recent archived tumor samples.

Exclusion Criteria

• Patients not of Native American descent or identity.
• Patient does not have archival tissue available.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adanma Ayanambakkam, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Countries

United States

Central Contacts

Lead Onco Nurse

Role: CONTACT

SCC-IIT-Office@ouhsc.edu

405-271-8777

Adanma Ayanambakkam, MD

Role: CONTACT

Adanma-Ayanambakkam@ouhsc.edu

405-271-4022

Facility Contacts

Adanma Ayanambakkam, MD

Role: primary

Adanma-Ayanambakkam@ouhsc.edu

405-271-4022

Other Identifiers

OU-SCC-NAT-Geno

Identifier Type: -

Identifier Source: org_study_id