Race-related Alternative Splicing: Novel Targets in Prostate Cancer

NCT ID: NCT03424213

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 169 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2021-07-14

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

white low aggressive

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

No interventions - retrospective data collection

Intervention Type: OTHER

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

white high aggressive

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

No interventions - retrospective data collection

Intervention Type: OTHER

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

white intermediate aggressive

intermediate aggressive = all other cases

No interventions - retrospective data collection

Intervention Type: 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 low aggressive

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

No interventions - retrospective data collection

Intervention Type: 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

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

No interventions - retrospective data collection

Intervention Type: 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 intermediate aggressive

intermediate aggressive = all other cases

No interventions - retrospective data collection

Intervention Type: OTHER

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

Interventions

No interventions - retrospective data collection

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Patierno, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00091092

Identifier Type: -

Identifier Source: org_study_id