Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •· Other histology subtype
结局指标
主要结局
genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.
时间窗: upon availability of genetic consultation report min 6 weeks
participants will also be followed for all treatments and responses until death
次要结局
未报告次要终点