Clinical trial NCT02341118: Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.
Official title: Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ovarian Cancer
Keywords: BRCA1/2 Mutational Status
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

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 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

Eligibility criteria: 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

Primary outcomes:
measure: genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.
timeFrame: upon availability of genetic consultation report min 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Amit Oza
role: PRINCIPAL_INVESTIGATOR
References: