Trials / Completed
CompletedNCT03871816
A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 14,532 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis | Saliva, blood, and/or archival tumor tissue will be collected from the participants with metastatic PC for genomic testing to confirm DRD status. |
Timeline
- Start date
- 2019-04-22
- Primary completion
- 2022-10-30
- Completion
- 2022-11-22
- First posted
- 2019-03-12
- Last updated
- 2023-12-11
Locations
338 sites across 25 countries: United States, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, Denmark, France, Germany, Israel, Italy, Malaysia, Netherlands, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT03871816. Inclusion in this directory is not an endorsement.