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

NCT06960798 | Recruiting

• 1 other identifier: OU-SCC-NAT-Geno
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Native American Men; Genomic Profile

Outcome Measures

Primary Outcomes (1)

• Difference in the genomic profiles of Prostate Cancer

  Comprehensively characterize the genomic profile of prostate cancer in Native American patients compared to Caucasian patients. Genetic testing will be conducted using Caris Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS).

  1-3 years

Secondary Outcomes (1)

• Comparison of Genomic Profiles

  1-3 years

Study Arms (1)

Native American Group

150 patients will be assigned in this group.

Other: Bio-specimen Collection; Other: Blood Draw

Interventions

Bio-specimen Collection OTHER

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

Native American Group

Blood Draw OTHER

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

Native American Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Must be male due to the type of cancer being observed it is not prevalent in females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical trial will focus on addressing the underrepresented Native American population served by the Urology Oncology Department at Stephenson Cancer Center. To broaden the scope of data, the trial will also involve other institutions, while maintaining its primary focus on the target population.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Archived tumor tissue collected at screening. Blood samples collected within the first year

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Adanma Ayanambakkam, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Onco Nurse

CONTACT

405-271-8777; SCC-IIT-Office@ouhsc.edu

Adanma Ayanambakkam, MD

CONTACT

405-271-4022; Adanma-Ayanambakkam@ouhsc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 7, 2025
• Study Start: May 2, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)