Clinical trial · Interventional
Radical Fimbriectomy for Young BRCA Mutation Carriers
Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma
NCT01608074CI-TRIAL-00105874FIMBRIECTOMIEactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| Hereditary Breast and Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histopathology SEE-FIM | Other | — | UNRESOLVED |
| Radical fimbriectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BRCA mutation carriers
- description
- Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM
- interventionNames
- Procedure: Radical fimbriectomy
- Other: Histopathology SEE-FIM
Primary outcomes (1)
- measure
- Rate of pelvic cancer
- timeFrame
- an expected average of 15 years
- description
- Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause
Secondary outcomes (8)
- measure
- Morbidity associated with the radical prophylactic fimbriectomy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Woman aged over 35 years * When project of childbearing is fulfilled * With a BRCA 1 or 2 mutation, or a family history of breast/ovarian cancer * Unprepared to undergo bilateral annexectomy * With or without breast cancer * Patient affiliated to health insurance * Dated and signed informed consent Exclusion Criteria: * Menopausal woman defined as : Bilateral oophorectomy without hysterectomy and amenorrhea more than 12 months and/or FSH\> 20 UI/l History of hysterectomy and FSH\> 20 UI/l * Pregnant or breastfeeding woman
References
Publications (2)
- RESULTWisztorski M, Aboulouard S, Roussel L, Duhamel M, Saudemont P, Cardon T, Narducci F, Robin YM, Lemaire AS, Bertin D, Hajjaji N, Kobeissy F, Leblanc E, Fournier I, Salzet M. Fallopian tube lesions as potential precursors of early ovarian cancer: a comprehensive proteomic analysis. Cell Death Dis. 2023 Sep 30;14(9):644. doi: 10.1038/s41419-023-06165-5. PMID 37775701
- RESULTLeblanc 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