Radical Fimbriectomy for Young BRCA Mutation Carriers
FIMBRIECTOMIE
3 other identifiers
interventional
123
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2012
CompletedFirst Submitted
Initial submission to the registry
May 15, 2012
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2033
March 18, 2026
March 1, 2026
21.6 years
May 15, 2012
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of pelvic cancer
Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause
an expected average of 15 years
Secondary Outcomes (8)
Morbidity associated with the radical prophylactic fimbriectomy
Up to 30 days after the surgery
Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens
Within 1 month after fimbriectomy, and within 1 month after oophorectomy
Incidence of breast cancer on patients without breast cancer before fimbriectomy, and incidence (de novo or recurrence) of breast cancer on the overall study population
an expected average of 15 years
Rate of secondary oophorectomies and associated morbidity, and reasons for oophorectomy if decided before the age of 50 et before menopausis
an expected average of 15 years
Proteomic profile of tissues from radical fimbriectomy
Up to 7 years after sample collection
- +3 more secondary outcomes
Study Arms (1)
BRCA mutation carriers
EXPERIMENTALWomen with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM
Interventions
Laparoscopic bilateral radical fimbriectomy : Complete resection of the tubes, from the uterine tube (up against the uterus) to the fimbriae, with resection of the part of the ovary adjacent to the ovarian fimbriae (adhering to the ovary)
Anatomopathological study of surgical specimens
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- CTD-CNOcollaborator
- Laboratoire PRISMcollaborator
Study Sites (14)
Polyclinique du Parc Rambot
Aix-en-Provence, France
Institut Bergonié
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Oscar Lambret
Lille, France
CHR-U
Lille, France
Clinique du Bois - Bourgogne Center
Lille, France
Hospices Civils de Lyon
Lyon, France
Institut Paoli Calmettes
Marseille, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, France
Centre Henri Becquerel
Rouen, France
IUCT-O Toulouse
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Hôpital Privé VA
Villeneuve-d'Ascq, France
Related Publications (2)
Wisztorski 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: 37775701RESULTLeblanc 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: 36831483RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos MARTINEZ-GOMEZ, MD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2012
First Posted
May 30, 2012
Study Start
January 9, 2012
Primary Completion (Estimated)
August 1, 2033
Study Completion (Estimated)
August 1, 2033
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share