Race-related Alternative Splicing: Novel Targets in Prostate Cancer

NCT03424213 | Completed

• 1 other identifier: Pro00091092
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Frequency of candidate race-related splice variants in localized prostate cancer of varying degrees of aggressiveness

  at the time of analysis

Study Arms (6)

white low aggressive

low aggressive = Gleason score \< 7 and stage cT1-cT2 and PSA \< 10 ng/ml

Other: No interventions - retrospective data collection

white high aggressive

high aggressive = Gleason score ≥ 8 or PSA \> 20 ng/ml or Gleason score = 7 and stage cT3-cT4

Other: No interventions - retrospective data collection

white intermediate aggressive

intermediate aggressive = all other cases

Other: No interventions - retrospective data collection

AA low aggressive

low aggressive = Gleason score \< 7 and stage cT1-cT2 and PSA \< 10 ng/ml

Other: No interventions - retrospective data collection

AA high aggressive

high aggressive = Gleason score ≥ 8 or PSA \> 20 ng/ml or Gleason score = 7 and stage cT3-cT4

Other: No interventions - retrospective data collection

AA intermediate aggressive

intermediate aggressive = all other cases

Other: No interventions - retrospective data collection

Interventions

No interventions - retrospective data collection OTHER

No new patients will be consented to this study. Only retrospective data will be collected on prostatectomy specimens and correlated with health data

AA high aggressive; AA intermediate aggressive; AA low aggressive; white high aggressive; white intermediate aggressive; white low aggressive

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes AA and white male patients having confirmed prostate cancer and enrolled in NC-LA PCaP, a population-based, case-only study of prostate cancer in AA and white men in NC and LA. Radical prostatectomy specimens will be selected from AA and white patients who have consented to NC-LA PCaP and have adequate tumor specimens of appropriate aggressiveness banked.

You may qualify if:

• Confirmed diagnosis of prostate cancer.
• Self-reported race of AA or white.
• 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.
• Classification of prostate cancer of low, intermediate or high aggressiveness, as defined by NC-LA PCaP.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

radical prostatectomy specimen

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Steve Patierno, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: January 30, 2018
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)