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

University of Oklahoma (OU)

Status: Begins enrollment in 2 months

Conditions: Prostate Cancer

Treatments: Other: Bio-specimen Collection; Other: Blood Draw

Study type: Observational

Funder types: Other

Identifiers

NCT06960798

OU-SCC-NAT-Geno

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Native American Group

Description:

150 patients will be assigned in this group.

Treatment:

Other: Blood Draw

Other: Bio-specimen Collection