Prospective Study of Risk-Reducing Salpingo-Oophorectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer: Extended Follow-Up of Select GOG-0199 Study Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,916
- 试验地点
- 140
- 主要终点
- Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer
研究概览
简要总结
This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer. Gathering information about genetic factors in women with an increased risk of ovarian cancer over time may help doctors learn more about the disease and find better methods of treatment and on-going care.
详细描述
PRIMARY OBJECTIVES:
I. To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal cancer, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known breast cancer susceptibility gene (BRCA)1/2 mutation carriers.
II. To develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy and women who have elected screening.
III. To compare the cancer rates between these two groups of women. IV. To better characterize the similarities and differences in cancer risk between BRCA mutation-positive families and BRCA mutation-negative/family history-positive families.
V. To develop preliminary estimates of overall and cancer-specific mortality, stratified by mutation status (BRCA1-positive, BRCA2-positive, BRCA1/2-negative).
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Enrolled on GOG-0199
- •Completed the original 5-year follow-up period OR is off-study due to pregnancy or development of a new cancer
- •Completed the Off-Study form (Form Q0-0199 submitted via SEDES)
- •No patients who were off-study before the end of the initial 5-year follow-up period (found to be ineligible or consent withdrawal)
排除标准
- 未提供
结局指标
主要结局
Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer
时间窗: Up to 5 years
Ovarian cancer mortality rates
时间窗: Up to 5 years
Cox proportional hazards models will be used to compare the incidence rates between the risk-reducing salpingo-oophorectomy (RRSO) and screening groups, adjusting for appropriate covariates. If necessary, modeling will be carried out in order to use non-proportional hazards models.
Breast cancer mortality rates
时间窗: Up to 5 years
Quality of life
时间窗: Up to 5 years
次要结局
未报告次要终点