BRCA1 MutationFIMBRIECTOMIENCT01608074
Radical Fimbriectomy for Young BRCA Mutation Carriers
A study testing Radical fimbriectomy and Histopathology SEE-FIM in people with BRCA1 Mutation and BRCA2 Mutation, run by Centre Oscar Lambret at 14 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- BRCA1 Mutation, BRCA2 Mutation, Hereditary Breast and Ovarian Cancer
- What is being tested?
- Radical fimbriectomy and Histopathology SEE-FIM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 14 sitesFrance
- Study dates
- 9 Jan 2012to Aug 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Polyclinique du Parc Rambot
Aix-en-Provence
Institut Bergonié
Bordeaux
Centre Jean Perrin
Clermont-Ferrand
Centre Oscar Lambret
Lille
CHR-U
Lille
Clinique du Bois - Bourgogne Center
Lille
Hospices Civils de Lyon
Lyon
Institut Paoli Calmettes
Marseille
Centre Antoine Lacassagne
Nice
Institut Curie
Paris
Centre Henri Becquerel
Rouen
IUCT-O Toulouse
Toulouse
Institut Gustave Roussy
Villejuif
Hôpital Privé VA
Villeneuve-d'Ascq
About this study
Official title: Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma
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.
Read the detailed description
Most of ovarian carcinomas related to BRCA 1 or 2 mutations are of fallopian tube origin and especially from its distant part called the fimbria. These tubal, ovarian or primary peritoneal carcinomas are quite always of high grade serous type. They cannot be effectively screened due to the quickness of their evolution. In this context, a laparoscopic bilateral salpingo-oophorectomy (BSO) is the recommended prophylactic procedure.
Some BRCA-mutated women are reluctant to undergo this procedure considering the numerous adverse effects on body and quality of life, especially when hormonal replacement is forbidden. This refusal makes them at risk of developing a serous pelvic carcinoma.
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
- Being tested
- Radical fimbriectomy, Histopathology SEE-FIM
- Keywords
- BRCA1, BRCA2, Prophylactic surgery, Salpingectomy, Fimbriectomy
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical fimbriectomyProcedure or surgery
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)
Histopathology SEE-FIMOther
Also called Sectioning and Extensively Examining the FIMbria
Anatomopathological study of surgical specimens
| Study group | Role | What they receive |
|---|---|---|
| BRCA mutation carriers | Experimental | Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer.
Radical fimbriectomy. Histopathology SEE-FIM Receives: Procedure: Radical fimbriectomy; Other: Histopathology SEE-FIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pelvic cancer
Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause
Measured: an expected average of 15 years
Secondary outcomes (8)
Morbidity associated with the radical prophylactic fimbriectomy
Morbidity will be assessed according to the Clavien-Dindo classification up to 30 days after the procedure and according to the NCI-CTCAE v4.0 grading scale beyond that time
Measured: Up to 30 days after the surgery
Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens
Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens
Measured: 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
Number of cases of breast cancer or breast cancer recurrence observed
Measured: 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
Number of oophorectomies and time between fimbriectomy and oophorectomy Complications according to NCI-CTCAE v4.0 grading scale
Measured: an expected average of 15 years
Proteomic profile of tissues from radical fimbriectomy
Immunostaining is realised on sections of ovary portion, fimbriae and fallopian tubes, then tumoral zones are selected for spatially resolved gun microproteomic analysis
Measured: Up to 7 years after sample collection
Proportion of menopausal women before oophorectomy or at the LPLV without oophorectomy, and rate patients who experienced early menopause (before the age of 40)
Number of cases of menopausis an early menopausis observed
Measured: an expected average of 15 years
Proportion of benign histological abnormalities on radical Fimbriectomy specimens
Number of benign histological abnormalities on the operative specimens
Measured: Within 1 month after fimbriectomy
Patient's satisfaction at distance from Radical Fimbriectomy
Patient satisfaction survey
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study start9 Jan 2012
- Primary completionAug 2033 (estimated)
- Study completionAug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BRCA1 MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- CTD-CNO, Laboratoire PRISM
- Responsible party
- Sponsor
- Investigators
- Carlos MARTINEZ-GOMEZ, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608074
- Sponsor's protocol ID
- FIMBRIECTOMIE-1106
- Other IDs
- PHRC-K11-106, 2011-A01213-38
- Acronym
- FIMBRIECTOMIE
- Status last verified
- Mar 2026
- First submitted
- 15 May 2012
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37775701Leblanc 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.
PubMed 36831483