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Recruiting NCT06960798

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

Observational Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bio-specimen Collection, Blood Draw.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 18 years — 100 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Bio-specimen Collection
    Tissue samples will be taken from existing archived collections and sent for further analysis.
  • Other Blood Draw
    Blood samples will be collected within the first year of enrollment.

Primary outcome measures

  • Difference in the genomic profiles of Prostate Cancer [Time frame: 1-3 years]
Secondary outcome measures (1)
  • Comparison of Genomic Profiles [Time frame: 1-3 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • OU Health Stephenson Cancer Center — Oklahoma City

Identifiers

NCT: NCT06960798 · OU-SCC-NAT-Geno

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗