Prostate Cancer, Renal Cell Carcinoma (RCC)
Conditions
Keywords
Genomic Profile, Native American
Brief summary
The purpose of this study is to analyze tumor tissue samples from patients of Native American identity with prespecified cancers of interest. 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) and Renal cell carcinoma (RCC) , 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 cohorts. Oversight will be maintained by the Institutional Review Board and an independent Native American 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
Tissue samples will be taken from existing archived collections and sent for further analysis.
OTHERBlood Draw
Blood samples will be collected within the first year of enrollment.
Sponsors
University of Oklahoma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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 and RCC (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-specific genomic and transcriptomic profiles in Native American patients | 1-3 years | The frequency and distribution of somatic genomic alterations, including single-nucleotide variants, insertions/deletions, copy-number alterations, tumor mutational burden, and clinically actionable alterations, together with gene-expression signatures and molecular pathway activity identified by whole-exome sequencing and whole-transcriptome sequencing in each disease-specific Native American cohort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differential genomic and transcriptomic features between Native American and non-Hispanic White cohorts | 1-3 years | Differences in the frequency and distribution of somatic genomic alterations, gene-expression signatures, molecular subtypes, and pathway-level enrichment between Native American disease-specific cohorts and prespecified publicly available or approved non-Hispanic White reference cohorts. |
Countries
United States
Contacts
CONTACTLead Onco Nurse
CONTACTAdanma Ayanambakkam, MD, MS
PRINCIPAL_INVESTIGATORAdanma Ayanambakkam, MD, MS
University of Oklahoma
Outcome results
None listed