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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Native American Group | 150 patients will be assigned in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-specimen Collection | Other | Tissue samples will be taken from existing archived collections and sent for further analysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Genomic Profiles | The study compares the Native American population with a reference Caucasian cohort to characterize molecular disparities and evaluate their clinical significance. | 1-3 years |
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Inclusion Criteria:
Exclusion Criteria:
Must be male due to the type of cancer being observed it is not prevalent in females.
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lead Onco Nurse | Contact | 405-271-8777 | SCC-IIT-Office@ouhsc.edu | |
| Adanma Ayanambakkam, MD | Contact | 405-271-4022 | Adanma-Ayanambakkam@ouhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adanma Ayanambakkam, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OU Health Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73117 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Archived tumor tissue collected at screening.
Blood samples collected within the first year
| Blood Draw | Other | Blood samples will be collected within the first year of enrollment. |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |