Determination of Prevalence and Features of HRRm mCRPC (ADAM) (ADAM)
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|ClinicalTrials.gov Identifier: NCT04712890|
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : February 25, 2021
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.
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||A Multi-center, Non-interventional, Prospective Cohort Study for Determination of Prevalence and Features of HRRm mCRPC (ADAM)|
|Actual Study Start Date :||October 23, 2020|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2022|
- Differences in demographics between patients with HRRm and HRRwt mCRPC [ Time Frame: Up to 1 year ]
- Differences in treatment patterns between patients with HRRm and HRRwt mCRPC [ Time Frame: Up to 1 year ]
- Differences in clinical characteristics between patients with HRRm and HRRwt mCRPC [ Time Frame: Up to 1 year ]
- Progression-free survival (PFS) rate (time to documentation of objective tumor progression/relapse) stratified by tissue HRR-related gene mutation status and by treatment pattern [ Time Frame: Up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712890
|Altay regional oncological hospital||Not yet recruiting|
|Barnaul, Russian Federation|
|Contact: Sergey Varlamov 7-3812-258217 firstname.lastname@example.org|
|Chelyabinsk oncology center||Recruiting|
|Chelyabinsk, Russian Federation|
|Contact: Galina Gopp 8 (351) 214-88-88 email@example.com|
|Sverdlovsk regional oncological hospital||Recruiting|
|Ekaterinburg, Russian Federation|
|Contact: Aleksandr Orlov +7 (343) 356-17-31 firstname.lastname@example.org|
|Moscow city oncological hospital N 2||Recruiting|
|Moscow, Russian Federation|
|Contact: Aleksandr Bystrov 7 495 536 01 00 email@example.com|
|Privolzhsky regional medical center||Recruiting|
|Nizhniy Novgorod, Russian Federation|
|Contact: Vagif Adtuev +7 (831) 428 81 88 firstname.lastname@example.org|
|Clinical oncology hospital of Omsk||Recruiting|
|Omsk, Russian Federation|
|Contact: Evgeny Kopyltsov 7-3812-258217 email@example.com|