An interventional study of Radical fimbriectomy and Histopathology SEE-FIM in BRCA1 Mutation, BRCA2 Mutation and Hereditary Breast and Ovarian Cancer, sponsored by Centre Oscar Lambret. Active, not recruiting at 14 sites in France. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Centre Oscar Lambret · Not applicable, Interventional, and Prevention
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.
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
57 studies on the registry are indexed under Hereditary Breast and Ovarian Cancer Syndrome; 13 are open to participants now.
This study's enrollment of 123 is close to the median of 121 across 40 interventional studies indexed under Hereditary Breast and Ovarian Cancer Syndrome.
Browse Hereditary Breast and Ovarian Cancer Syndrome studies →Centre Oscar Lambret is the lead sponsor of 127 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Bilateral oophorectomy without hysterectomy and amenorrhea more than 12 months and/or FSH> 20 UI/l History of hysterectomy and FSH> 20 UI/l
Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM
Procedure: Radical fimbriectomy · Other: Histopathology SEE-FIM
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
Also known as: Sectioning and Extensively Examining the FIMbria
Rate of pelvic cancer
Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause
Time frame: an expected average of 15 years
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: an expected average of 15 years
Proportion of benign histological abnormalities on radical Fimbriectomy specimens
Number of benign histological abnormalities on the operative specimens
Time frame: Within 1 month after fimbriectomy
Patient's satisfaction at distance from Radical Fimbriectomy
Patient satisfaction survey
Time frame: Up to 10 years
Plan to share: No
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Hereditary Breast and Ovarian Cancer Syndrome→
Centre Oscar Lambret