Clinical trial NCT06960798: Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno)
Official title: Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (Nat-Geno)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Keywords: Native American Men
Genomic Profile
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Difference in the genomic profiles of Prostate Cancer
timeFrame: 1-3 years
Secondary outcomes:
measure: Comparison of Genomic Profiles
timeFrame: 1-3 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Adanma Ayanambakkam, MD
role: PRINCIPAL_INVESTIGATOR
References: