Viewing Study NCT02317120



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Last Modification Date: 2024-10-26 @ 11:35 AM
Study NCT ID: NCT02317120
Status: COMPLETED
Last Update Posted: 2017-02-01
First Post: 2014-12-11

Brief Title: BRCA1 and BRCA2 Mutation in Romanian Population a Study of Genotype - Phenotype Correlation at Diagnosis With Prospective Disease Outcome and Survival
Sponsor: Alexandru Eniu
Organization: Prof Dr I Chiricuta Institute of Oncology

Study Overview

Official Title: BRCA1 and BRCA2 Mutation in Romanian Population a Study of Genotype - Phenotype Correlation at Diagnosis With Prospective Disease Outcome and Survival
Status: COMPLETED
Status Verified Date: 2017-01
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: None
Brief Summary: Primary objective To determine BRCA1 and BRCA2 variants in 250 Romanian women with breastovarian cancer selected for likeliness to harbor germline mutations in these genes by specific criteria for high-risk status including age at disease onset

Secondary objective Considering the fact that BRCA testing is not a routine procedure in Romania and mutation prevalence varies in different populations we intend to look for the founder mutation in our population running full BRCA genes sequencing to a representative population sample This would allow a more targeted approach to real-life practice and would ensure personalized solutions for every patient in need
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