Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 123
- 试验地点
- 14
- 主要终点
- Rate of pelvic cancer
研究概览
简要总结
Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.
详细描述
Most of ovarian carcinomas related to BRCA 1 or 2 mutations are of fallopian tube origin and especially from its distant part called the fimbria. These tubal, ovarian or primary peritoneal carcinomas are quite always of high grade serous type. They cannot be effectively screened due to the quickness of their evolution. In this context, a laparoscopic bilateral salpingo-oophorectomy (BSO) is the recommended prophylactic procedure.
Some BRCA-mutated women are reluctant to undergo this procedure considering the numerous adverse effects on body and quality of life, especially when hormonal replacement is forbidden. This refusal makes them at risk of developing a serous pelvic carcinoma.
The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman aged over 35 years
- •When project of childbearing is fulfilled
- •With a BRCA 1 or 2 mutation, or a family history of breast/ovarian cancer
- •Unprepared to undergo bilateral annexectomy
- •With or without breast cancer
- •Patient affiliated to health insurance
- •Dated and signed informed consent
排除标准
- •Menopausal woman defined as :
- •Bilateral oophorectomy without hysterectomy and amenorrhea more than 12 months and/or FSH> 20 UI/l History of hysterectomy and FSH> 20 UI/l
- •Pregnant or breastfeeding woman
研究组 & 干预措施
BRCA mutation carriers
Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer.
Radical fimbriectomy. Histopathology SEE-FIM
干预措施: Radical fimbriectomy (Procedure)
BRCA mutation carriers
Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer.
Radical fimbriectomy. Histopathology SEE-FIM
干预措施: Histopathology SEE-FIM (Other)
结局指标
主要结局
Rate of pelvic cancer
时间窗: an expected average of 15 years
Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause
次要结局
- Rate of secondary oophorectomies and associated morbidity, and reasons for oophorectomy if decided before the age of 50 et before menopausis(an expected average of 15 years)
- Incidence of breast cancer on patients without breast cancer before fimbriectomy, and incidence (de novo or recurrence) of breast cancer on the overall study population(an expected average of 15 years)
- Proportion of menopausal women before oophorectomy or at the LPLV without oophorectomy, and rate patients who experienced early menopause (before the age of 40)(an expected average of 15 years)
- Morbidity associated with the radical prophylactic fimbriectomy(Up to 30 days after the surgery)
- Proportion of benign histological abnormalities on radical Fimbriectomy specimens(Within 1 month after fimbriectomy)
- Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens(Within 1 month after fimbriectomy, and within 1 month after oophorectomy)
- Patient's satisfaction at distance from Radical Fimbriectomy(Up to 10 years)
- Proteomic profile of tissues from radical fimbriectomy(Up to 7 years after sample collection)