[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571905":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":39,"locations":48,"responsibleParty":319,"collaborators":44,"id":321,"slug":322,"hasResults":323,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":323,"sex":329,"minAge":330,"maxAge":331,"enrollmentInfo":332,"targetDuration":44,"studyType":335,"phases":336,"briefSummary":338,"conditions":339,"keywords":345,"overallStatus":357,"whyStopped":44,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":367},{"fullName":5,"class":6},"Centre Oscar Lambret","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fimbriectomy Followed by Delayed Oophorectomy (F-DO)","EXPERIMENTAL","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.",[13],"Procedure: Fimbriectomy Followed by Delayed Oophorectomy (F-DO)",{"label":15,"type":16,"description":17,"interventionNames":18},"Bilateral Salpingo-Oophorectomy (BSO)","ACTIVE_COMPARATOR","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\u002F2 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.",[19],"Procedure: Bilateral Salpingo-Oophorectomy",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","This intervention involves two stages:\n\n1. Fimbriectomy: A preventive surgical procedure that removes the fimbrial end of the fallopian tubes, including adjacent ovarian tissue, while preserving ovarian function to avoid premature menopause.\n2. Delayed Oophorectomy: The removal of ovaries, performed at menopause or later, depending on patient preference and clinical guidelines.\n\n   * The F-DO strategy aims to reduce the risk of tubo-ovarian or primary peritoneal carcinoma, which often originates in the fallopian tubes, while minimizing the adverse effects of premature menopause such as cardiovascular disease and osteoporosis",[9],[26],"fimbriectomy",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Bilateral Salpingo-Oophorectomy","This standard surgical intervention involves the removal of both fallopian tubes and ovaries (BSO) to eliminate the risk of tubo-ovarian or primary peritoneal carcinoma. It is typically recommended for women with a genetic predisposition (e.g., BRCA1\u002F2 mutations) around the age of 40-45. While highly effective in preventing cancer, BSO induces premature menopause, which may result in long-term side effects such as increased cardiovascular risk, osteoporosis, and cognitive decline.",[15],[32],"BSO",[34,37],{"name":35,"affiliation":5,"role":36},"Carlos MARTINEZ GOMEZ, MD","STUDY_DIRECTOR",{"name":38,"affiliation":5,"role":36},"Audrey MAILLIEZ, MD",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Marie VANSEYMORTIER, PharmaD","CONTACT","0320295918",null,"promotion@o-lambret.fr",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":45},"Fanny BEN OUNE",[49,69,82,95,108,121,134,142,155,163,175,185,198,213,226,234,244,254,263,276,289,298,311],{"facility":50,"status":44,"city":51,"state":52,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Centre Léon Bérard","Lyon","France","FR",{"type":55,"coordinates":56},"Point",[57,58],4.84789,45.74906,{"lat":58,"lon":57},[61,64,67],{"name":62,"role":63,"phone":44,"phoneExt":44,"email":44},"Léa ROSSI, MD","PRINCIPAL_INVESTIGATOR",{"name":65,"role":66,"phone":44,"phoneExt":44,"email":44},"Pauline ROCHEFORT, MD","SUB_INVESTIGATOR",{"name":68,"role":66,"phone":44,"phoneExt":44,"email":44},"Nicolas CHOPIN, MD",{"facility":70,"status":44,"city":71,"state":52,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Institut universitaire du cancer de Toulouse","Toulouse",{"type":55,"coordinates":73},[74,75],1.44367,43.60426,{"lat":75,"lon":74},[78,80],{"name":79,"role":63,"phone":44,"phoneExt":44,"email":44},"Gwenael FERRON, MD",{"name":81,"role":66,"phone":44,"phoneExt":44,"email":44},"Laurence GLADIEFF, MD",{"facility":83,"status":44,"city":84,"state":52,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Centre Hospitalier de Valenciennes","Valenciennes",{"type":55,"coordinates":86},[87,88],3.52506,50.35909,{"lat":88,"lon":87},[91,93],{"name":92,"role":63,"phone":44,"phoneExt":44,"email":44},"Yves BORGHESI, MD",{"name":94,"role":66,"phone":44,"phoneExt":44,"email":44},"Alfane BRAHIMI, MD",{"facility":96,"status":44,"city":97,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Institut Bergonié","Bordeaux",{"type":55,"coordinates":99},[100,101],-0.58046,44.84124,{"lat":101,"lon":100},[104,106],{"name":105,"role":63,"phone":44,"phoneExt":44,"email":44},"Frédéric GUYON, MD",{"name":107,"role":66,"phone":44,"phoneExt":44,"email":44},"Virginie BUBIEN, MD",{"facility":109,"status":44,"city":110,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Centre François Baclesse","Caen",{"type":55,"coordinates":112},[113,114],-0.35912,49.18585,{"lat":114,"lon":113},[117,119],{"name":118,"role":63,"phone":44,"phoneExt":44,"email":44},"Roman ROUZIER, MD",{"name":120,"role":66,"phone":44,"phoneExt":44,"email":44},"Pascaline BERTHET, MD",{"facility":122,"status":44,"city":123,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Centre Jean Perrin","Clermont-Ferrand",{"type":55,"coordinates":125},[126,127],3.08682,45.77969,{"lat":127,"lon":126},[130,132],{"name":131,"role":63,"phone":44,"phoneExt":44,"email":44},"Caroline CORNOU, MD",{"name":133,"role":66,"phone":44,"phoneExt":44,"email":44},"Mathilde GAY BELLILE, MD",{"facility":135,"status":44,"city":136,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":137,"geoPoint":141,"contacts":44},"Centre Hospitalier Universitaire Dijon Bourgogne","Dijon",{"type":55,"coordinates":138},[139,140],5.01391,47.31344,{"lat":140,"lon":139},{"facility":143,"status":44,"city":144,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Centre hospitalier universitaire Grenoble-Alpes","Grenoble",{"type":55,"coordinates":146},[147,148],5.71479,45.17869,{"lat":148,"lon":147},[151,153],{"name":152,"role":63,"phone":44,"phoneExt":44,"email":44},"Anne Cécile PHILIPPE, MD",{"name":154,"role":66,"phone":44,"phoneExt":44,"email":44},"LEGRAND, MD",{"facility":156,"status":44,"city":157,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":158,"geoPoint":162,"contacts":44},"Centre Hospitalier Universitaire de Lille","Lille",{"type":55,"coordinates":159},[160,161],3.05512,50.63391,{"lat":161,"lon":160},{"facility":5,"status":44,"city":157,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":164,"geoPoint":166,"contacts":167},{"type":55,"coordinates":165},[160,161],{"lat":161,"lon":160},[168,172,173],{"name":169,"role":42,"phone":170,"phoneExt":44,"email":171},"Pauline SMIS","+333 20 29 59 59","investigation@o-lambret.fr",{"name":35,"role":63,"phone":44,"phoneExt":44,"email":44},{"name":174,"role":66,"phone":44,"phoneExt":44,"email":44},"AUDREY MAILLIEZ, MD",{"facility":176,"status":44,"city":157,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":177,"geoPoint":179,"contacts":180},"Clinique du Bois",{"type":55,"coordinates":178},[160,161],{"lat":161,"lon":160},[181,183],{"name":182,"role":63,"phone":44,"phoneExt":44,"email":44},"Jean Yves CHARVOLIN, MD",{"name":184,"role":66,"phone":44,"phoneExt":44,"email":44},"Claude ADENIS, MD",{"facility":186,"status":44,"city":187,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Institut Paoli-Calmettes","Marseille",{"type":55,"coordinates":189},[190,191],5.38107,43.29695,{"lat":191,"lon":190},[194,196],{"name":195,"role":63,"phone":44,"phoneExt":44,"email":44},"Camille JAUFFRET, MD",{"name":197,"role":66,"phone":44,"phoneExt":44,"email":44},"Catherine NOGUES, MD",{"facility":199,"status":44,"city":200,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU","Nantes",{"type":55,"coordinates":202},[203,204],-1.55336,47.21725,{"lat":204,"lon":203},[207,209,211],{"name":208,"role":63,"phone":44,"phoneExt":44,"email":44},"Célia CHALUMEAU, MD",{"name":210,"role":66,"phone":44,"phoneExt":44,"email":44},"ABADIE Caroline, MD",{"name":212,"role":66,"phone":44,"phoneExt":44,"email":44},"Capucine DELNATTE, MD",{"facility":214,"status":44,"city":215,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Centre Antoine Lacassagne","Nice",{"type":55,"coordinates":217},[218,219],7.26608,43.70313,{"lat":219,"lon":218},[222,224],{"name":223,"role":63,"phone":44,"phoneExt":44,"email":44},"Véronique MARI, MD",{"name":225,"role":66,"phone":44,"phoneExt":44,"email":44},"Marie GOSSET, MD",{"facility":227,"status":44,"city":228,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":229,"geoPoint":233,"contacts":44},"Gustave Roussy","Paris",{"type":55,"coordinates":230},[231,232],2.3488,48.85341,{"lat":232,"lon":231},{"facility":235,"status":44,"city":228,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"Hôpital de la Pitié Salpêtrière - AP-HP",{"type":55,"coordinates":237},[231,232],{"lat":232,"lon":231},[240,242],{"name":241,"role":63,"phone":44,"phoneExt":44,"email":44},"Catherine UZAN, MD",{"name":243,"role":66,"phone":44,"phoneExt":44,"email":44},"Clémence EVREVIN, MD",{"facility":245,"status":44,"city":228,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":246,"geoPoint":248,"contacts":249},"Hôpital Institut CURIE",{"type":55,"coordinates":247},[231,232],{"lat":232,"lon":231},[250,252],{"name":251,"role":63,"phone":44,"phoneExt":44,"email":44},"Virginie FOURCHOTTE, MD",{"name":253,"role":66,"phone":44,"phoneExt":44,"email":44},"Chrystelle COLAS, MD",{"facility":255,"status":44,"city":228,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":256,"geoPoint":258,"contacts":259},"Hôpital Tenon AP-HP",{"type":55,"coordinates":257},[231,232],{"lat":232,"lon":231},[260,262],{"name":261,"role":63,"phone":44,"phoneExt":44,"email":44},"Cyril TOUBOUL, MD",{"name":243,"role":66,"phone":44,"phoneExt":44,"email":44},{"facility":264,"status":44,"city":265,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Institut Godinot","Reims",{"type":55,"coordinates":267},[268,269],4.02853,49.26526,{"lat":269,"lon":268},[272,274],{"name":273,"role":63,"phone":44,"phoneExt":44,"email":44},"Judicael HOTTON, MD",{"name":275,"role":66,"phone":44,"phoneExt":44,"email":44},"Fanny BRAYOTEL, MD",{"facility":277,"status":44,"city":278,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Centre Henri Becquerel","Rouen",{"type":55,"coordinates":280},[281,282],1.09932,49.44313,{"lat":282,"lon":281},[285,287],{"name":286,"role":63,"phone":44,"phoneExt":44,"email":44},"Agathe CROUZET, MD",{"name":288,"role":66,"phone":44,"phoneExt":44,"email":44},"Jean Christophe TERY, MD",{"facility":290,"status":44,"city":278,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":291,"geoPoint":293,"contacts":294},"Hôpitaux Privés Rouennais",{"type":55,"coordinates":292},[281,282],{"lat":282,"lon":281},[295,297],{"name":296,"role":63,"phone":44,"phoneExt":44,"email":44},"Benoit RESCH, MD",{"name":288,"role":63,"phone":44,"phoneExt":44,"email":44},{"facility":299,"status":44,"city":300,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Hôpital de Saint-Cloud","Saint-Cloud",{"type":55,"coordinates":302},[303,304],2.20289,48.84598,{"lat":304,"lon":303},[307,309],{"name":308,"role":63,"phone":44,"phoneExt":44,"email":44},"Claire BONNEAU, MD",{"name":310,"role":66,"phone":44,"phoneExt":44,"email":44},"Emmanuelle MOURET-FOURME, MD",{"facility":312,"status":44,"city":313,"state":44,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":314,"geoPoint":318,"contacts":44},"Hôpital Simone Veil - CH de Troyes","Troyes",{"type":55,"coordinates":315},[316,317],4.08524,48.30073,{"lat":317,"lon":316},{"type":320,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","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":333,"type":334},1100,"ESTIMATED","INTERVENTIONAL",[337],"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.",[340,341,342,343,344],"Tubo-ovarian Carcinoma","High-grade Serous Carcinoma","Primary Peritoneal Carcinoma Stage III","Primary Peritoneal Carcinoma Stage IV","Primary Peritoneal Carcinoma",[346,347,348,349,350,351,352,353,32,354,355,356],"Tubo-ovarian carcinoma","Primary peritoneal carcinoma","BRCA1\u002F2 mutations","RAD51C\u002FD mutations","PALB2 mutation","Preventive surgery","Fimbriectomy","Bilateral salpingo-oophorectomy","Cancer prevention","Premenopausal women","Genetic predisposition to cancer","NOT_YET_RECRUITING","2026-03-16",{"date":360,"type":361},"2026-03-17","ACTUAL",{"date":363,"type":334},"2027-03",{"date":365,"type":334},"2071-03",{"name":5,"class":6},23]