Prostate CancerNCT06960798
Characterizing the Genomic Landscape of Cancer in Native American Populations (NAT-Geno)
An observational study of Prostate Cancer and Renal Cell Carcinoma (RCC), run by University of Oklahoma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Renal Cell Carcinoma (RCC)
- What is being tested?
- Bio-specimen Collection and Blood Draw
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to 30 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This clinical trial will focus on addressing the underrepresented Native American population served by the Urology Oncology Department at Stephenson Cancer Center.
Who may be able to join
- 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.
Who cannot join
- Patients not of Native American descent or identity.
- Patient does not have archival tissue available.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
Adanma Ayanambakkam, MD, 405-271-4022, Adanma-Ayanambakkam@ou.edu
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer, Renal Cell Carcinoma (RCC)
- Being tested
- Bio-specimen Collection, Blood Draw
- Keywords
- Genomic Profile, Native American
- Medical subject headings
- Prostatic Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-specimen CollectionOther
Tissue samples will be taken from existing archived collections and sent for further analysis.
Blood DrawOther
Blood samples will be collected within the first year of enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Cohort (A) Native American Men with Prostate Cancer | 150 patients will be assigned in this cohort Receives: Other: Bio-specimen Collection; Other: Blood Draw | |
| Cohort (B) Native American Patients with Renal Cell Carcinoma | 150 patients will be assigned in this cohort Receives: Other: Bio-specimen Collection; Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific genomic and transcriptomic profiles in Native American patients
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.
Measured: 1-3 years
Secondary outcomes (1)
Differential genomic and transcriptomic features between Native American and non-Hispanic White cohorts
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.
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start2 Nov 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adanma Ayanambakkam, MD, MS, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960798
- Sponsor's protocol ID
- OU-SCC-NAT-Geno
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Genomic Landscape of Cancer in Native American Populations (NAT-Geno)
- ClinicalTrials.gov ID
- NCT06960798
- Acronym / sponsor ID
- OU-SCC-NAT-Geno
- Conditions
- Prostate Cancer, Renal Cell Carcinoma (RCC)
- Keywords
- Genomic Profile, Native American
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort (A) Native American Men with Prostate Cancer | – | Other: Bio-specimen Collection, Other: Blood Draw150 patients will be assigned in this cohort |
| Cohort (B) Native American Patients with Renal Cell Carcinoma | – | Other: Bio-specimen Collection, Other: Blood Draw150 patients will be assigned in this cohort |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical trial will focus on addressing the underrepresented Native American population served by the Urology Oncology Department at Stephenson Cancer Center.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients not of Native American descent or identity.
- Patient does not have archival tissue available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-specimen CollectionTissue samples will be taken from existing archived collections and sent for further analysis. | Other | Cohort (A) Native American Men with Prostate Cancer, Cohort (B) Native American Patients with Renal Cell Carcinoma |
| Blood DrawBlood samples will be collected within the first year of enrollment. | Other | Cohort (A) Native American Men with Prostate Cancer, Cohort (B) Native American Patients with Renal Cell Carcinoma |
Primary outcome
Disease-specific genomic and transcriptomic profiles in Native American patients
Time frame: 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.
1 secondary outcome
Differential genomic and transcriptomic features between Native American and non-Hispanic White cohorts
Time frame: 1-3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adanma Ayanambakkam, MD, MS principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Renal Cell Carcinoma (RCC), run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lead Onco Nurse (405-271-8777, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-specific genomic and transcriptomic profiles in Native American patients (time frame: 1-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.