Clinical trial · Observational
A Bidirectional Cohort Study on Prophylactic Resection Surgery in Populations at Moderate-to-High Risk for Hereditary Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this multi-center observational study is to learn about the effectiveness and safety of different prophylactic (preventive) surgical options in women at moderate-to-high genetic risk for hereditary ovarian cancer (HOC). The main questions it aims to answer are: Does individualized prophylactic surgery (such as removing fallopian tubes now and delaying ovary removal) effectively reduce the risk of developing ovarian cancer compared to standard care or close monitoring? How do these different surgical interventions affect a woman's ovarian function and quality of life? What Participants Will Do: Participants who are healthy carriers of specific genetic mutations (such as BRCA1/2, RAD51C/D, etc.) will be followed in a bidirectional cohort. Depending on the medical care and surgical path they choose with their doctors (Standard RRSO, Delayed Oophorectomy, or Close Monitoring), researchers will collect their clinical data, surgical pathology results, and follow-up information regarding cancer incidence and quality of life for 3 years.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Label 1: Standard RRSO Group. Label 2: Individualized RS-DO Group. Label 3: Close Monitoring Group
- description
- Description of Label 1: Participants undergoing concurrent bilateral salpingo-oophorectomy per guidelines. Description of Label 2: Participants undergoing salpingectomy with delayed oophorectomy to preserve hormones.Description of Label 3: Participants declining surgery and choosing regular ultrasound and CA-125 surveillance.
Primary outcomes (1)
- measure
- Incidence of Ovarian Cancer
- timeFrame
- From the date of enrollment/surgery up to 15 years.
- description
- The primary efficacy endpoint is the development of histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer among high-risk mutation carriers in different intervention groups.
Secondary outcomes (4)
- measure
- Incidence of Breast Cancer
- timeFrame
- From the date of enrollment up to 15 years.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Gender: Female. Age: 18 years or older at the time of enrollment.Genetic Risk: Documented carriers of pathogenic or likely pathogenic germline mutations in high-risk ovarian cancer susceptibility genes (including BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2). Data Availability: Willing to provide informed consent and allow access to clinical records, genetic testing reports, and follow-up data (bidirectional cohort). Psychosocial Status: Ability to complete quality of life and psychological assessment scales (e.g., GCS, SF-36, FSFI). Exclusion Criteria: * Prior Malignancy: History of ovarian, fallopian tube, or primary peritoneal cancer prior to the baseline intervention. Synchronous Malignancy: Diagnosis of any other advanced-stage malignancy. Inability to Follow-up: Significant psychological, social, or geographical factors that would prevent regular long-term follow-up (3 years). Previous Extensive Pelvic Surgery: History of extensive pelvic surgery that precludes the feasibility of laparoscopic prophylactic salpingectomy or oophorectomy.
References
Publications (12)
- BACKGROUNDKuchenbaecker KB, Hopper JL, Barnes DR, Phillips KA, Mooij TM, Roos-Blom MJ, Jervis S, van Leeuwen FE, Milne RL, Andrieu N, Goldgar DE, Terry MB, Rookus MA, Easton DF, Antoniou AC; BRCA1 and BRCA2 Cohort Consortium; McGuffog L, Evans DG, Barrowdale D, Frost D, Adlard J, Ong KR, Izatt L, Tischkowitz M, Eeles R, Davidson R, Hodgson S, Ellis S, Nogues C, Lasset C, Stoppa-Lyonnet D, Fricker JP, Faivre L, Berthet P, Hooning MJ, van der Kolk LE, Kets CM, Adank MA, John EM, Chung WK, Andrulis IL, Southey M, Daly MB, Buys SS, Osorio A, Engel C, Kast K, Schmutzler RK, Caldes T, Jakubowska A, Simard J, Friedlander ML, McLachlan SA, Machackova E, Foretova L, Tan YY, Singer CF, Olah E, Gerdes AM, Arver B, Olsson H. Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers. JAMA. 2017 Jun 20;317(23):2402-2416. doi: 10.1001/jama.2017.7112. PMID 28632866
- BACKGROUNDLukey A, Howard AF, Mei AJ, Law MR, Huntsman D, Pearce CL, Meza R, Hanley GE. Risk-reducing salpingectomy: considerations from an OBGYN perspective. BMC Cancer. 2025 Jun 6;25(1):1011. doi: 10.1186/s12885-025-14384-6. PMID 40481395
- BACKGROUNDLeblanc E, Narducci F, Ferron G, Mailliez A, Charvolin JY, Houssein EH, Guyon F, Fourchotte V, Lambaudie E, Crouzet A, Fouche Y, Gouy S, Collinet P, Caquant F, Pomel C, Golfier F, Vaini-Cowen V, Fournier I, Salzet M, Tresch E, Probst A, Lemaire AS, Deley ML, Hudry D. Prophylactic Radical Fimbriectomy with Delayed Oophorectomy in Women with a High Risk of Developing an Ovarian Carcinoma: Results of a Prospective National Pilot Study. Cancers (Basel). 2023 Feb 10;15(4):1141. doi: 10.3390/cancers15041141. PMID 36831483
- BACKGROUNDSia J, Lane EF, Fierheller CT, Oxley S, Kalra A, Sideris M, Wei X, Mansour L, Idahl A, Fraser H, Ganesan S, Deshmukh P, Ganesan R, Hanson H, Saridogan E, Hamed H, McCluggage WG, Legood R, Sasieni P, Evans DG, Menon U, Brentnall A, Manchanda R; PROTECTOR team. Estimands for Clinical Effectiveness of Risk-Reducing Early Salpingectomy in Women With High Risk of Ovarian Cancer. JAMA Netw Open. 2025 Sep 2;8(9):e2532195. doi: 10.1001/jamanetworkopen.2025.32195. PMID 40956577
- Steenbeek MP, van Bommel MHD, intHout J, Peterson CB, Simons M, Roes KCB, Kets M, Norquist BM, Swisher EM, Hermens RPMG; TUBA-WISP II consortium; Lu KH, de Hullu JA. TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol. Int J Gynecol Cancer. 2023 Jun 5;33(6):982-987. doi: 10.1136/ijgc-2023-004377.