Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- To evaluate the non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.
研究概览
简要总结
This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence
详细描述
The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk.
PRIMARY OBJECTIVE:
To evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.
SECONDARY OBJECTIVE:
Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
- •Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB
- •The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation.
- •No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.
- •Presence of at least one fallopian tube.
- •Participants may have a personal history of non-ovarian malignancy.
- •Informed consent must be obtained and documented.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Postmenopausal status (natural menopause or due to (cancer) treatment)
- •A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can be considered.
- •Wish for second stage RRO within two years after RRS (if clear at enrollment)
- •Legally incapable
- •Prior bilateral salpingectomy
- •A personal history of ovarian, fallopian tube, or peritoneal cancer
- •Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
研究组 & 干预措施
Risk-Reducing Salpingo-Oophorectomy-RRSO
Can help to lower the risk of ovarian cancer as well as the standard-of-care risk-reducing procedure involving the removal of the fallopian tubes and ovaries (risk-reducing salpingo-oophorectomy-RRSO)
干预措施: Risk-Reducing Salpingo-Oophorectomy-RRSO (Other)
Risk-Reducing Salpingectomy-RRS
Can help to lower the risk of ovarian cancer with a delayed removal of 1.
干预措施: RIsk-Reducing Salpingectomy (RRS) (Other)
Risk-Reducing Oophorectomy-RRO
Can help to lower the risk of ovarian cancer removing both fallopian tubes.
干预措施: Risk-Reducing Oophorectomy-RRO (Other)
结局指标
主要结局
To evaluate the non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.
时间窗: through study completion, an average of 15 years
次要结局
未报告次要终点