Trial record 1 of 2 for:
janssen prevalence | prostate cancer
A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03871816 |
Recruitment Status :
Recruiting
First Posted : March 12, 2019
Last Update Posted : December 30, 2020
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
Tracking Information | |||||
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First Submitted Date | March 11, 2019 | ||||
First Posted Date | March 12, 2019 | ||||
Last Update Posted Date | December 30, 2020 | ||||
Actual Study Start Date | April 22, 2019 | ||||
Estimated Primary Completion Date | July 26, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer | ||||
Official Title | Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Study population consists of male participants diagnosed with metastatic prostate cancer who will be evaluated for the prevalence for DNA-repair gene defects. | ||||
Condition | Metastatic Prostate Cancer | ||||
Intervention | 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.
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Study Groups/Cohorts | Participants with Metastatic Prostate Cancer
Participants with metastatic prostate Cancer (PC) will be evaluated for the prevalence of DNA-repair gene defects (DRDs) and will be assessed for biomarker eligibility status for niraparib interventional studies. Participants will be consented to saliva, blood, and/or archival tumor tissue testing for the presence or absence of DNA-repair gene defects.
Intervention: Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
10000 | ||||
Original Estimated Enrollment |
2540 | ||||
Estimated Study Completion Date | September 16, 2023 | ||||
Estimated Primary Completion Date | July 26, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Argentina, Australia, Brazil, Bulgaria, Canada, Denmark, France, Israel, Korea, Republic of, Malaysia, Poland, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States | ||||
Removed Location Countries | Belgium, Netherlands, New Zealand | ||||
Administrative Information | |||||
NCT Number | NCT03871816 | ||||
Other Study ID Numbers | CR108591 64091742PCR0002 ( Other Identifier: Janssen Research & Development, LLC ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Janssen Research & Development, LLC | ||||
Study Sponsor | Janssen Research & Development, LLC | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Janssen Research & Development, LLC | ||||
Verification Date | December 2020 |