A Comparative Effectiveness Study of Cancer Risk Management for Women at Elevated Genetic Risk of Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cost-effectiveness of RRSO versus OCS
研究概览
简要总结
This research trial collects information about types of treatment and the cost of these procedures in women with elevated genetic risk for ovarian cancer who participated on the Gynecology Oncology Group (GOG)-0199 trial. Gathering information about women at elevated genetic risk for ovarian cancer may help doctors learn more about risk reduction procedures and the cost of these procedures.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the cost-effectiveness, defined as cost per quality-adjusted life-year saved, of risk-reducing salpingo-oophorectomy (RRSO) versus ovarian cancer screening (OCS) for women at elevated genetic risk of ovarian cancer over a five-year period, using data from GOG-0199 to model survival.
SECONDARY OBJECTIVES:
I. To estimate the cost-effectiveness, defined as cost per quality-adjusted life-year saved, of RRSO versus OCS for women at elevated genetic risk of ovarian cancer over a lifetime, using stage-specific cohorts and population-based data to model long-term survival. (Exploratory) II. To use value of information (VOI) methodology to set future research priorities aimed at developing evidence-based approaches to the management of women who are at elevated genetic risk of ovarian cancer. (Exploratory)
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Women who were eligible and evaluable for GOG-0199, a prospective, non-randomized, natural history study
- •Data collected from GOG-0199 available
排除标准
- 未提供
结局指标
主要结局
Cost-effectiveness of RRSO versus OCS
时间窗: 6 months
Incidence and stage at diagnosis of ovarian, fallopian tube, and peritoneal cancers in the OCS arm and in the RRSO arm will be collected. This information will be obtained from the CANCER UPDATE FORM (CA-0199) and the Ovarian Surgery Form (C-0199). Summary of the number and timing of screening serum tests, pelvic ultrasound, and surgery procedures will be used to calculate costs, and will be incorporated into the model of Markov stage that corresponds to the study timepoint at which these studies were performed.
次要结局
未报告次要终点