Clinical trial · Observational
Race-related Alternative Splicing: Novel Targets in Prostate Cancer
- 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)
Data from evaluating prostate cancer (PCa) biopsy tissue from AA and white patients has led to the discovery of alternative splicing as a novel molecular mechanism underlying more aggressive PCa in AA men. Coded archival radical prostatectomy tissue specimens and annotated clinical data, questionnaire data, and ancestral genotyping data will be obtained from the racially diverse and federally funded North Carolina-Louisiana PCa Project (NC-LA PCaP). We will use 33 tissue specimens from each of the following 6 groups (n=198 total): white low aggressive, white intermediate aggressive, white high aggressive, AA low aggressive, AA intermediate aggressive and AA high aggressive. The aforementioned tissues will first be screened for tumor content and Gleason grade by a genitourinary pathologist. To identify race-related splice variants, RNA will be isolated for targeted sequencing of prioritized race-related alternatively spliced genes using the NimbleGen SeqCap Target Enrichment, SeqCap RNA System to capture regions of interest and the Illumina HiSeq sequencing platform to sequence these regions at a depth and coverage sufficient to accurately call alternative splicing events.
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 |
|---|---|---|---|
| No interventions - retrospective data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- white low aggressive
- description
- low aggressive = Gleason score \< 7 and stage cT1-cT2 and PSA \< 10 ng/ml
- interventionNames
- Other: No interventions - retrospective data collection
- label
- white high aggressive
- description
- high aggressive = Gleason score ≥ 8 or PSA \> 20 ng/ml or Gleason score = 7 and stage cT3-cT4
- interventionNames
- Other: No interventions - retrospective data collection
- label
- white intermediate aggressive
- description
- intermediate aggressive = all other cases
- interventionNames
- Other: No interventions - retrospective data collection
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of prostate cancer. 2. Self-reported race of AA or white. 3. Availability of five unstained slides per radical prostatectomy specimen and an associated Hematoxylin and Eosin stained slide for each radical prostatectomy specimen from NC-LA PCaP. 4. Classification of prostate cancer of low, intermediate or high aggressiveness, as defined by NC-LA PCaP. Exclusion Criteria: 1\. Obtained radical prostatectomy tissue is inadequate for RNA analysis and/or is not positive for adenocarcinoma of the prostate of low, intermediate or high aggressiveness.
References
Publications (0)
Data not yet available