Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02341118|
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : December 12, 2019
BRCA1 or BRCA2 genes, are implicated in 10-15% of ovarian cancer cases, increased to 22% germline BRCA1/2 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 BRCA1/2 screening to all patients with high grade serous ovarian cancer. This information may help in selection of future treatment options and genetic testing for BRCA1/2 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 BRCA1/2 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.
|Condition or disease||Intervention/treatment|
|Ovarian Cancer||Genetic: BRCA genetic data|
· To provide genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.
- To track the number of women with high grade serous ovarian cancer who are being screened in Princess Margaret Cancer Center for mutations in BRCA1/2
- To track accrual rates and clinical outcomes in patients with high grade serous ovarian cancer who are BRCA1/2-positive
- To correlate impact of BRCA1/2 mutational status on clinical outcome
- To track utilization of genetic counseling services at Princess Margaret Cancer Centre
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
- Genetic: BRCA genetic data
Two blood samples will be taken which is part of the standard of care. Tumor samples will be obtained from previous biopsy or surgery prior to this study for DNA testing
- genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer. [ Time Frame: upon availability of genetic consultation report min 6 weeks ]participants will also be followed for all treatments and responses until death
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): NCT02341118
|Contact: David Gutierrez||416-946-4501 ext 4821||David.Gutierrez@uhn.ca|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Amit Oza 416-946-2818|
|Principal Investigator:||Amit Oza||University Health Network, Toronto|