Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04712890
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2021-01-08
Brief Title:
Determination of Prevalence and Features of HRRm mCRPC ADAM
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multi-center Non-interventional Prospective Cohort Study for Determination of Prevalence and Features of HRRm mCRPC ADAM
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAM
Brief Summary:
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 Sources
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
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 Sources
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None