[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461346":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":169,"collaborators":28,"id":171,"slug":172,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":28,"eligibilityCriteria":176,"healthyVolunteers":173,"sex":177,"minAge":178,"maxAge":28,"enrollmentInfo":179,"targetDuration":28,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":28,"overallStatus":45,"whyStopped":28,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,13,18],{"label":9,"type":6,"description":10,"interventionNames":11},"Risk-Reducing Salpingectomy-RRS","Can help to lower the risk of ovarian cancer with a delayed removal of 1.",[12],"Other: RIsk-Reducing Salpingectomy (RRS)",{"label":14,"type":6,"description":15,"interventionNames":16},"Risk-Reducing Oophorectomy-RRO","Can help to lower the risk of ovarian cancer removing both fallopian tubes.",[17],"Other: Risk-Reducing Oophorectomy-RRO",{"label":19,"type":6,"description":20,"interventionNames":21},"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)",[22],"Other: Risk-Reducing Salpingo-Oophorectomy-RRSO",[24,29,31],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RIsk-Reducing Salpingectomy (RRS)","complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure",[9],null,{"type":6,"name":14,"description":26,"armGroupLabels":30,"otherNames":28},[14],{"type":6,"name":19,"description":26,"armGroupLabels":32,"otherNames":28},[19],[34],{"name":35,"affiliation":5,"role":36},"Roni Wilke, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":28,"email":41},"CONTACT","(713) 822-4502","rnitecki@mdanderson.org",[43,62,77,91,105,116,131,145,154],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Dana Farber Cancer Institute","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.05977,42.35843,{"lat":55,"lon":54},[58,61],{"name":59,"role":39,"phone":28,"phoneExt":28,"email":60},"Colleen 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General","Houston","Texas","77026",{"type":52,"coordinates":137},[138,139],-95.36327,29.76328,{"lat":139,"lon":138},[142,144],{"name":35,"role":39,"phone":28,"phoneExt":28,"email":143},"rnitechi@mdanderson.org",{"name":35,"role":36,"phone":28,"phoneExt":28,"email":28},{"facility":146,"status":45,"city":133,"state":134,"zip":147,"country":49,"countryCode":50,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"M D Anderson Cancer Center","77030",{"type":52,"coordinates":149},[138,139],{"lat":139,"lon":138},[152],{"name":35,"role":39,"phone":153,"phoneExt":28,"email":41},"713-822-4502",{"facility":155,"status":45,"city":156,"state":157,"zip":158,"country":49,"countryCode":50,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"University of Washington","Seattle","Washington","98195",{"type":52,"coordinates":160},[161,162],-122.33207,47.60621,{"lat":162,"lon":161},[165,168],{"name":166,"role":39,"phone":28,"phoneExt":28,"email":167},"Barbara Norquist, MD","bnorquis@uw.edu",{"name":166,"role":36,"phone":28,"phoneExt":28,"email":28},{"type":170,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100461346","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-100461346",false,"NCT05287451","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","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and\u002For RAD51D gene germline mutation.\n2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2.\n\n   * The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation.\n3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.\n4. Presence of at least one fallopian tube.\n5. Participants may have a personal history of non-ovarian malignancy.\n6. Informed consent must be obtained and documented.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n1. Postmenopausal status (natural menopause or due to (cancer) treatment)\n\n   * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n   * 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.\n2. Wish for second stage RRO within two years after RRS (if clear at enrollment)\n3. Legally incapable\n4. Prior bilateral salpingectomy\n5. A personal history of ovarian, fallopian tube, or peritoneal cancer\n6. Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.","FEMALE","18 Years",{"count":180,"type":181},100,"ESTIMATED","INTERVENTIONAL",[184],"NA","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",[187,188],"Ovarian Cancer","Fallopian Tube Cancer","2026-06-24",{"date":191,"type":192},"2026-06-26","ACTUAL",{"date":194,"type":192},"2022-05-10",{"date":196,"type":181},"2026-12-26",{"name":5,"class":6},9]