Prostate CancerPCaP splicingNCT03424213
Race-related Alternative Splicing: Novel Targets in Prostate Cancer
An observational study of Prostate Cancer, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 14 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
- Being tested
- No interventions - retrospective data collection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions - retrospective data collectionOther
No new patients will be consented to this study. Only retrospective data will be collected on prostatectomy specimens and correlated with health data
| Study group | Role | What they receive |
|---|---|---|
| white low aggressive | low aggressive = Gleason score < 7 and stage cT1-cT2 and PSA < 10 ng/ml Receives: 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 Receives: Other: No interventions - retrospective data collection | |
| white intermediate aggressive | intermediate aggressive = all other cases Receives: Other: No interventions - retrospective data collection | |
| AA low aggressive | low aggressive = Gleason score < 7 and stage cT1-cT2 and PSA < 10 ng/ml Receives: 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 Receives: Other: No interventions - retrospective data collection | |
| AA intermediate aggressive | intermediate aggressive = all other cases Receives: Other: No interventions - retrospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of candidate race-related splice variants in localized prostate cancer of varying degrees of aggressiveness
Measured: at the time of analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start30 Jan 2018
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Patierno, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424213
- Sponsor's protocol ID
- Pro00091092
- Acronym
- PCaP splicing
- Status last verified
- Jan 2022
- First submitted
- 31 Jan 2018
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Race-related Alternative Splicing: Novel Targets in Prostate Cancer
- ClinicalTrials.gov ID
- NCT03424213
- Acronym / sponsor ID
- PCaP splicing / Pro00091092
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| white low aggressive | – | Other: No interventions - retrospective data collectionlow aggressive = Gleason score < 7 and stage cT1-cT2 and PSA < 10 ng/ml |
| white high aggressive | – | Other: No interventions - retrospective data collectionhigh aggressive = Gleason score ≥ 8 or PSA > 20 ng/ml or Gleason score = 7 and stage cT3-cT4 |
| white intermediate aggressive | – | Other: No interventions - retrospective data collectionintermediate aggressive = all other cases |
| AA low aggressive | – | Other: No interventions - retrospective data collectionlow aggressive = Gleason score < 7 and stage cT1-cT2 and PSA < 10 ng/ml |
| AA high aggressive | – | Other: No interventions - retrospective data collectionhigh aggressive = Gleason score ≥ 8 or PSA > 20 ng/ml or Gleason score = 7 and stage cT3-cT4 |
| AA intermediate aggressive | – | Other: No interventions - retrospective data collectionintermediate aggressive = all other cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions - retrospective data collectionNo new patients will be consented to this study. Only retrospective data will be collected on prostatectomy specimens and correlated with health data | Other | AA high aggressive, AA intermediate aggressive, AA low aggressive, white high aggressive, white intermediate aggressive, white low aggressive |
Primary outcome
Frequency of candidate race-related splice variants in localized prostate cancer of varying degrees of aggressiveness
Time frame: at the time of analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Patierno, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of candidate race-related splice variants in localized prostate cancer of varying degrees of aggressiveness (time frame: at the time of analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.