Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT05287451
Status:
RECRUITING
Last Update Posted:
2025-11-05
First Post:
2022-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the 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 in BRCA1/2 gene germline mutation carriers.', 'timeFrame': 'through study completion, an average of 15 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer', 'Fallopian Tube Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk.\n\nPRIMARY OBJECTIVE:\n\nTo 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 in BRCA1/2 gene germline mutation carriers.\n\nSECONDARY OBJECTIVE:\n\nIncidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy.\n\nEXPLORATORY OBJECTIVE:\n\nEstimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': '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/or 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\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)\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.'}, 'identificationModule': {'nctId': 'NCT05287451', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2021-1089'}, 'secondaryIdInfos': [{'id': 'NCI-2022-01291', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Risk-Reducing Salpingectomy-RRS', 'description': 'Can help to lower the risk of ovarian cancer with a delayed removal of 1.', 'interventionNames': ['Other: RIsk-Reducing Salpingectomy (RRS)']}, {'type': 'OTHER', 'label': 'Risk-Reducing Oophorectomy-RRO', 'description': 'Can help to lower the risk of ovarian cancer removing both fallopian tubes.', 'interventionNames': ['Other: Risk-Reducing Oophorectomy-RRO']}, {'type': 'OTHER', 'label': 'Risk-Reducing Salpingo-Oophorectomy-RRSO', 'description': '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)', 'interventionNames': ['Other: Risk-Reducing Salpingo-Oophorectomy-RRSO']}], 'interventions': [{'name': 'RIsk-Reducing Salpingectomy (RRS)', 'type': 'OTHER', 'description': 'complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure', 'armGroupLabels': ['Risk-Reducing Salpingectomy-RRS']}, {'name': 'Risk-Reducing Oophorectomy-RRO', 'type': 'OTHER', 'description': 'complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure', 'armGroupLabels': ['Risk-Reducing Oophorectomy-RRO']}, {'name': 'Risk-Reducing Salpingo-Oophorectomy-RRSO', 'type': 'OTHER', 'description': 'complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure', 'armGroupLabels': ['Risk-Reducing Salpingo-Oophorectomy-RRSO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colleen Feltmate', 'role': 'CONTACT', 'email': 'cfeltmate@bwh.harvard.edu'}, {'name': 'Colleen Feltmate', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie N Bakkum-Gamez, MD', 'role': 'CONTACT', 'email': 'bakkum.jamie@mayo.edu'}, {'name': 'Jamie N Bakkum-Gamez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrea Hagemann, MD', 'role': 'CONTACT'}, {'name': 'Andrea Hagemann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'WU St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Blank, MD', 'role': 'CONTACT', 'email': 'Stephanie.Blank@mountsinai.org'}, {'name': 'Stephanie Blank, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Health System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kara Long-Roche, MD', 'role': 'CONTACT', 'email': 'longrock@mskcc.org'}, {'name': 'Kara Long-Roche, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Kim, MD', 'role': 'CONTACT', 'email': 'Sarah.Kim@pennmedicine.upenn.edu'}, {'name': 'Sarah Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77026', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roni Wilke, MD', 'role': 'CONTACT', 'email': 'rnitechi@mdanderson.org'}, {'name': 'Roni Wilke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lyndon Baines Johnson General', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roni Wilke, MD', 'role': 'CONTACT', 'email': 'rnitecki@mdanderson.org', 'phone': '713-822-4502'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Norquist, MD', 'role': 'CONTACT', 'email': 'bnorquis@uw.edu'}, {'name': 'Barbara Norquist, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Roni Wilke, MD', 'role': 'CONTACT', 'email': 'rnitecki@mdanderson.org', 'phone': '(713) 822-4502'}], 'overallOfficials': [{'name': 'Roni Wilke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}