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Metadata

Name
Determination of Prevalence and Features of HRRm mCRPC (ADAM)
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT04712890
Description
Study design:

This study is local, multi-center, prospective, cohort study to collect real world data
related mCRPC patients, prevalence of HRRm and to assess possible influence of HRRm on
treatment outcomes. No additional procedures besides those already used in the routine
clinical practice will be applied to the patients. Treatment assignment will be done
according to the current practice.

Data Source(s):

For testing archival samples (formalin fixed and paraffin embedded [FFPE]) from primary tumor
will be used . 15 HRR genes (BRCA1, BRCA2, ATM, BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL,
PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D and RAD54L) will be analyzed using NGS in dedicated
central laboratory facilities. Choice of laboratory for each center will be made based on
logistical proximity. Each NGS laboratory will have to determine and report clinical
significance of alterations found using database search or other predictors to classify
variants as deleterious or suspected deleterious. VUS have to be reported separately. Benign
variants will be not reported in this study.

All clinical and demographic data for patients with finished therapy will be collected in
prospective or retrospective (where applicable) manner during the study visits. The second
visit will take place when the disease progression or death is occurs or in a year after the
first visit whichever happens first. Data will be entered in the eCRF. The site investigator
will be responsible for ensuring that all required data is collected and entered into the
eCRF with the involvement of clinical research organization.

It is estimated that approximately 300 patients will be enrolled in the first stage. After
interim analysis total number of the patients can be increased, depending on the number of
NGS failures. It is estimated that approximately 30 sites in total will be participating in
the study.
Data or Study Types
clinical trial
Source Organization
Unknown
Access Conditions
available
Year
2021
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT04712890

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