TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 76
- 主要终点
- High grade serous (ovarian) cancer incidence
研究概览
简要总结
The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.
详细描述
In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
- •Age at inclusion;
- •BRCA1: 25-40 years
- •BRCA2: 25-45 years
- •RAD51C, RAD51D, BRIP1: 25-50 years
- •Childbearing completed
- •Presence of at least one fallopian tube
- •Participants may have a personal history of non-ovarian malignancy
- •Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.
排除标准
- •Postmenopausal status (natural menopause or due to treatment)
- •Wish for second stage RRO within two years after RRS
- •Legally incapable
- •Prior bilateral salpingectomy
- •A personal history of ovarian, fallopian tube or peritoneal cancer
- •Current diagnosis or treatment for malignant disease
研究组 & 干预措施
Risk-reducing salpingectomy with delayed oophorectomy
Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.
干预措施: Risk-reducing salpingectomy with delayed oophorectomy (Procedure)
Risk-reducing salpingo-oophorectomy
Risk-reducing salpingo-oophorectomy.
干预措施: Risk-reducing salpingo-oophorectomy (Procedure)
结局指标
主要结局
High grade serous (ovarian) cancer incidence
时间窗: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
High grade serous (ovarian) cancer incidence
次要结局
- Incidence of (pre)malignant findings in tubes/ovaries(6 weeks after each surgery)
- Incidence of pelvic cancer (other than ovarian cancer)(Up to the age of 70)
- Peri-operative morbidity and mortality(6 weeks after each surgery)
- Incidence of breast cancer(Up to the age of 70)
- Uptake of risk reducing oophorectomy(Up to the age of 70)
研究者
Joanne A. de Hullu, MD, PhD
Dr. J.A. de Hullu, MD, PhD
University Medical Center Nijmegen