Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT04104893
Description:
None of the biospecimens will be destroyed. Unused specimens will be used for future research to access clinical data indefinitely. Subjects can request to have all of their specimens destroyed at the end of the study. The research blood and tumor tissue specimens will not be marked with any personal identifiers. As soon as they are collected by a study personnel, the samples will be labeled with a code. The key to the code will remain locked in the research office that is only accessed by study personnel. Only coded specimens will be sent to commercial vendors and VA GLAHS in West LA.
The study investigators will perform research testing on their tissue specimens that is independent of the genetic analysis to be performed at commercial vendor. There are no plans to share the results of other testing performed on their specimens. These results are only for research purposes. However, certain exploratory biomarker test results may be shared with the subject.
Study:
NCT04104893
Study Brief:
A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation