Clinical trial · Observational
Molecular Mechanisms Underlying Prostate Cancer Disparities
Molecular Mechanisms Underlying Prostate Cancer Disparities.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to further elucidate the molecular mechanisms underlying prostate cancer disparities. In previous work the investigators have identified a set of differentially deregulated genes in African American versus Caucasian American prostate cancer. Based on these findings, they hypothesize that they will be able to validate these targets, originally identified in the previous work conducted at The George Washington University Medical Center, in an independent Duke University Medical Center cohort of prostate cancer specimens. In addition, the investigators hypothesize that they will be able to discover novel targets in the Duke University Medical Center cohort of prostate cancer specimens because of regional differences.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy or prostatectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Caucasian
- description
- Caucasian subjects having a biopsy or prostatectomy.
- interventionNames
- Device: Biopsy or prostatectomy
- label
- African American
- description
- African American subjects having a biopsy or prostatectomy.
- interventionNames
- Device: Biopsy or prostatectomy
Primary outcomes (1)
- measure
- Proportion of high and low expression of identified gene targets in Caucasian and African American specimens
- timeFrame
- up to 2 years
- description
- Total RNA will be interrogated for mRNA expression patterns with the Affymetrix Human Exon 1.0 ST GeneChip. Microarray data will be normalized by quantile normalization with background correction. Targeted RNA sequencing of the previously identified genetic factors specific to African American prostate cancer will confirm altered expression and alternative splicing in these deregulated genes. The Agilent Technologies SureSelect RNA Custom Capture Kit will capture and sequence transcripts. Epigenetic analyses of the genetic factors specific to African American prostate cancer will identify DNA methylation and histone modification patterns in these deregulated genes. The Sequenom EpiTYPER will screen for differential methylation and methylation differences will be quantified using pyrosequencing. Differential histone modification patterns will be explored. Analysis will be performed on 33 prostate cancer biopsy specimens from each of 6 groups stratified by race and Gleason grade.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected malignancy of prostate cancer * Self-reported race of African American or Caucasian American * Age \>/= 18 years * Able to read, understand and sign an informed consent document Exclusion Criteria: * Collected tumor tissue is inadequate for DNA and RNA analysis and/or is not positive for adenocarcinoma of the prostate. * Patients with prior systemic therapy will not be eligible for the study, i.e. radiation or chemo or immunotherapy.
References
Publications (0)
Data not yet available