Evaluation of Risk Control of Advanced Stage Tubo-ovarian or Primary Peritoneal Carcinoma Associated With Ovarian Carcinoma Risk-reducing Strategies, Including Fimbriectomy With Delayed Oophorectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,100
- 试验地点
- 23
- 主要终点
- Incidence of Advanced-Stage (Stage III or IV) Tubo-Ovarian or Primary Peritoneal Carcinoma
研究概览
简要总结
• FIMBRIMENOP-2402 study aims to evaluate the long-term management of cancer risks in premenopausal women who have a genetic predisposition to tubo-ovarian or primary peritoneal carcinoma, such as mutations in BRCA1, BRCA2, RAD51C, RAD51D, or PALB2 genes. This study offers an alternative to standard preventive surgery (bilateral salpingo-oophorectomy or BSO) by exploring the use of fimbriectomy (removal of the fallopian tube's fimbria) followed by delayed oophorectomy (removal of ovaries at menopause).
It's a pragmatic multicenter trial conducted across various medical centers, employing a non-randomized controlled preference design to compare two preventive surgical strategies:
- Fimbriectomy followed by delayed oophorectomy (F-DO).
- Bilateral salpingo-oophorectomy (BSO).
The primary objective is to compare the long-term efficacy of two preventive surgical strategies :
- Fimbriectomy followed by delayed oophorectomy (F-DO).
- Bilateral salpingo-oophorectomy (BSO).
As for the design of the study, participants choose their preferred surgical strategy during or after oncogenetic counseling, ensuring patient autonomy in decision-making.
• Follow-Up: Long-term follow-up includes clinical assessments, data collection from medical networks, and integration with national health databases to track outcomes up to the age of 70.
This is the first French comparative study in real-world settings and is classified as interventional research (RIPH1) under French regulations, given the need to validate fimbriectomy efficacy.
详细描述
- The FIMBRIMENOP-2402 study is a pragmatic, multicenter, interventional trial (RIPH1) designed to evaluate long-term management strategies for reducing cancer risk in premenopausal women genetically predisposed to tubo-ovarian or primary peritoneal carcinoma. Women carrying mutations in BRCA1, BRCA2, RAD51C, RAD51D, or PALB2 genes are the primary focus of this investigation.
- Objectives
The primary objective is to evaluate, on a long-term horizon, the control of the risk of advanced stage tubo-ovarian or primary peritoneal carcinoma according to the chosen care pathway, and more specifically whether F-DO is non inferior to BSO, in women with a germline mutation predisposing to the risk of high grade serous tubo-ovarian or primary peritoneal carcinoma.
The study aims to determine whether F-DO is non-inferior to BSO in controlling the risk of advanced-stage tubo-ovarian or primary peritoneal carcinoma in high-risk women.
The secondary objectives include evaluating the benefit-risk ratio of these approaches by assessing:
- Menopause-related side effects, such as cardiovascular and osteoporosis-related events.
- Surgical complications and overall survival.
- Long-term oncological outcomes, including breast cancer risks.
- Patient-reported preferences and compliance with the chosen pathway.
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
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman between 35 to 50 years
- •Addressed to or followed in an oncogenetic counselling
- •Identified risk of tubo-ovarian or primary peritoneal carcinoma based on mutational status (BRCA1, BRCA 2, RAD51C, RAD51D, PALB2). The list of considered mutations may be extended during the study.
- •Written informed consent
- •Patient covered by the French "Social Security"
排除标准
- •Prior bilateral oophorectomy and/or bilateral salpingectomy for any reason (prophylactic surgery or other)
- •Personal history of ovarian, fallopian tube or primary peritoneal cancer
- •Menopause defined by
- •In women without prior chemotherapy If no prior hysterectomy: the absence of menses for at least 12 months, or FSH > 20 UI/L with low estrogen level with no identified gynecological or endocrine explanation. Amenorrhea related to an intrauterine device, vaginal ring or estrogen-progestin pill will not be considered as menopause.
- •If prior hysterectomy: FSH >20 UI/L with low estrogen level (with or without vasomotor symptoms, genitourinary symptoms)
- •In women with prior chemotherapy: the absence of menses for at least 24 months
- •In all women with progesterone-loaded intra-uterine device (IUD): FSH > 20 UI/L with low estrogen level
- •Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)
- •Patient under guardianship or curatorship
研究组 & 干预措施
Fimbriectomy Followed by Delayed Oophorectomy (F-DO)
Participants in this arm will undergo fimbriectomy, a surgical procedure to remove the fimbrial end of the fallopian tubes, while preserving ovarian function. A delayed oophorectomy (removal of the ovaries) will be performed at menopause or later, based on individual timing and preferences. This approach aims to reduce the risk of advanced-stage tubo-ovarian or primary peritoneal carcinoma while minimizing the adverse effects of premature menopause.
干预措施: Fimbriectomy Followed by Delayed Oophorectomy (F-DO) (Procedure)
Bilateral Salpingo-Oophorectomy (BSO)
Participants in this arm will undergo a bilateral salpingo-oophorectomy (BSO), the standard preventive surgical strategy, involving the removal of both fallopian tubes and ovaries. This procedure is performed around the recommended age of 40-45 years for women with BRCA1/2 mutations or similar high-risk genetic predispositions. The primary objective is to eliminate the risk of tubo-ovarian or primary peritoneal carcinoma, though it induces premature menopause.
干预措施: Bilateral Salpingo-Oophorectomy (Procedure)
结局指标
主要结局
Incidence of Advanced-Stage (Stage III or IV) Tubo-Ovarian or Primary Peritoneal Carcinoma
时间窗: Up to 70 years of age
The study evaluates the long-term incidence of advanced-stage (Stage III or IV) tubo-ovarian or primary peritoneal carcinoma. This measure will be assessed using annual clinical evaluations, patient questionnaires, medical records, and data extracted from the French National Health Database (SNDS) and regional oncogenetic networks. Time from study entry to cancer diagnosis will be calculated, with death without cancer considered as a competing event. Data will be censored at the last follow-up visit for participants alive without cancer.
次要结局
- Incidence of Any-Stage Tubo-Ovarian or Primary Peritoneal Carcinoma(Up to 70 years of age)
- Age at Menopause(Over the study period (up to age 70).)
- Incidence of Cardiovascular Events and Osteoporosis-Related Events(Over the study period (up to age 70))
- Overall Survival(From study entry to death from any cause.)
- Surgical Complications(30 days following the surgery)