Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.

Ovarian Cancer Clinical Trial

Official title:

Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02341118
• Other study ID #: BRCA Screening
• Status: Terminated
• Start date: May 2014
• Est. completion date: May 8, 2023

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 109
• Est. completion date: May 8, 2023
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with high grade serous carcinoma originating from the ovaries, fallopian tube or peritoneal cavity; subtype of high grade endometrioid and clear cell ovarian cancer could be eligible in the exploratory cohort

• Patient must be =18 years old

• All patients must have sufficient archival tumor tissue for molecular analysis

• All patients must consent to have a genetic testing

• All patients must have signed and dated an informed consent form

Exclusion Criteria:

· Other histology subtype

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.	participants will also be followed for all treatments and responses until death	upon availability of genetic consultation report min 6 weeks