Ignite Creation Date:
2024-05-06 @ 3:39 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02341118
Status:
TERMINATED
Last Update Posted:
2023-07-27
First Post:
2014-11-27
Brief Title:
Capturing BRCA12 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Capturing BRCA12 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study did not collect sufficient data for primary endpoint analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BRCA1 or BRCA2 genes are implicated in 10-15 of ovarian cancer cases increased to 22 germline BRCA12 mutation frequency in patients with high grade serous histology subtype including those women who have no family history of breast or ovarian cancer With the rapid advancement of therapeutics targeted this population this protocol seeks to provide genetic BRCA12 screening to all patients with high grade serous ovarian cancer This information may help in selection of future treatment options and genetic testing for BRCA12 may be used to potentially prevent a proportion of cancer for the family members
This study will be an opportunity for patient to improve access at genetic and molecular testing for BRCA12 mutation which could impact her future treatment option Moreover this study will allow to prospectively assess the proportion of patients with BRCA mutation in ovarian cancer and describe the type of mutations identified in a large population
This study will be an opportunity for patient to improve access at genetic and molecular testing for BRCA12 mutation which could impact her future treatment option Moreover this study will allow to prospectively assess the proportion of patients with BRCA mutation in ovarian cancer and describe the type of mutations identified in a large population
Detailed Description:
Primary Objectives
To provide genomic profiling for BRCA1 and BRCA2 mutational status in patients with high grade serous ovarian cancer
Secondary Objectives
To track the number of women with high grade serous ovarian cancer who are being screened in Princess Margaret Cancer Center for mutations in BRCA12
To track accrual rates and clinical outcomes in patients with high grade serous ovarian cancer who are BRCA12-positive
To correlate impact of BRCA12 mutational status on clinical outcome
To track utilization of genetic counseling services at Princess Margaret Cancer Centre
To provide genomic profiling for BRCA1 and BRCA2 mutational status in patients with high grade serous ovarian cancer
Secondary Objectives
To track the number of women with high grade serous ovarian cancer who are being screened in Princess Margaret Cancer Center for mutations in BRCA12
To track accrual rates and clinical outcomes in patients with high grade serous ovarian cancer who are BRCA12-positive
To correlate impact of BRCA12 mutational status on clinical outcome
To track utilization of genetic counseling services at Princess Margaret Cancer Centre
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