Characterizing the Genomic Landscape of Cancer in Native American Populations (NAT-Geno)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-100
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Patients not of Native American descent or identity.
Patient does not have archival tissue available.
Trial population
This clinical trial will focus on addressing the underrepresented Native American population served by the Urology Oncology Department at Stephenson Cancer Center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bio-specimen Collection
Other interventionTissue samples will be taken from existing archived collections and sent for further analysis.
Blood Draw
Other interventionBlood samples will be collected within the first year of enrollment.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Cohort (A) Native American Men with Prostate Cancer2 interventions
Group B: Cohort (B) Native American Patients with Renal Cell Carcinoma2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1-3 yearsSecondary 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.
Time frame
1-3 yearsSponsors and contacts
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Source ClinicalTrials.gov