[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tubo-ovarian-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tubo-ovarian-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100571905","risk-reducing-strategies-including-fimbriectomy-in-women-with-a-germline-mutation-predisposing-to-ovarian-or-pelvic-cancer-100571905",false,"NCT06726330","Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer","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","FIMBRIMENOP","Inclusion Criteria:\n\n1. Woman between 35 to 50 years\n2. Addressed to or followed in an oncogenetic counselling\n3. 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.\n4. Written informed consent\n5. Patient covered by the French \"Social Security\"\n\nExclusion Criteria:\n\n1. Prior bilateral oophorectomy and\u002For bilateral salpingectomy for any reason (prophylactic surgery or other)\n2. Personal history of ovarian, fallopian tube or primary peritoneal cancer\n3. Menopause defined by\n\n   • In women without prior chemotherapy If no prior hysterectomy: the absence of menses for at least 12 months, or FSH \\> 20 UI\u002FL 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.\n\n   If prior hysterectomy: FSH \\>20 UI\u002FL with low estrogen level (with or without vasomotor symptoms, genitourinary symptoms)\n   * In women with prior chemotherapy: the absence of menses for at least 24 months\n   * In all women with progesterone-loaded intra-uterine device (IUD): FSH \\> 20 UI\u002FL with low estrogen level\n4. Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)\n5. Patient under guardianship or curatorship","FEMALE","35 Years","50 Years",{"count":21,"type":22},1100,"ESTIMATED","INTERVENTIONAL",[25],"NA","• 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).\n\nIt's a pragmatic multicenter trial conducted across various medical centers, employing a non-randomized controlled preference design to compare two preventive surgical strategies:\n\n1. Fimbriectomy followed by delayed oophorectomy (F-DO).\n2. Bilateral salpingo-oophorectomy (BSO).\n\nThe primary objective is to compare the long-term efficacy of two preventive surgical strategies :\n\n1. Fimbriectomy followed by delayed oophorectomy (F-DO).\n2. Bilateral salpingo-oophorectomy (BSO).\n\nAs for the design of the study, participants choose their preferred surgical strategy during or after oncogenetic counseling, ensuring patient autonomy in decision-making.\n\n• 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.\n\nThis 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.",[28,29,30,31,32],"Tubo-ovarian Carcinoma","High-grade Serous Carcinoma","Primary Peritoneal Carcinoma Stage III","Primary Peritoneal Carcinoma Stage IV","Primary Peritoneal Carcinoma",[34,35,36,37,38,39,40,41,42,43,44,45],"Tubo-ovarian carcinoma","Primary peritoneal carcinoma","BRCA1\u002F2 mutations","RAD51C\u002FD mutations","PALB2 mutation","Preventive surgery","Fimbriectomy","Bilateral salpingo-oophorectomy","BSO","Cancer prevention","Premenopausal women","Genetic predisposition to cancer","NOT_YET_RECRUITING","2026-03-16",{"date":49,"type":50},"2026-03-17","ACTUAL",{"date":52,"type":22},"2027-03",{"date":54,"type":22},"2071-03",{"name":56,"class":57},"Centre Oscar Lambret","OTHER",23]