BRCA1 Mutation, BRCA2 Mutation, Hereditary Breast and Ovarian Cancer
Conditions
Keywords
BRCA1, BRCA2, Prophylactic surgery, Salpingectomy, Fimbriectomy
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.
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
Interventions
PROCEDURERadical fimbriectomy
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)
OTHERHistopathology SEE-FIM
Anatomopathological study of surgical specimens
Sponsors
Centre Oscar Lambret
CTD-CNO
Laboratoire PRISM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of pelvic cancer | an expected average of 15 years | Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity associated with the radical prophylactic fimbriectomy | Up to 30 days after the surgery | 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 |
| Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens | Within 1 month after fimbriectomy, and within 1 month after oophorectomy | Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens |
| 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 | Number of cases of breast cancer or breast cancer recurrence observed |
| 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 | Number of oophorectomies and time between fimbriectomy and oophorectomy Complications according to NCI-CTCAE v4.0 grading scale |
| Proteomic profile of tissues from radical fimbriectomy | Up to 7 years after sample collection | Immunostaining is realised on sections of ovary portion, fimbriae and fallopian tubes, then tumoral zones are selected for spatially resolved gun microproteomic analysis |
| Proportion of menopausal women before oophorectomy or at the LPLV without oophorectomy, and rate patients who experienced early menopause (before the age of 40) | an expected average of 15 years | Number of cases of menopausis an early menopausis observed |
| Proportion of benign histological abnormalities on radical Fimbriectomy specimens | Within 1 month after fimbriectomy | Number of benign histological abnormalities on the operative specimens |
| Patient's satisfaction at distance from Radical Fimbriectomy | Up to 10 years | Patient satisfaction survey |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCarlos MARTINEZ-GOMEZ, MD
Centre Oscar Lambret
Outcome results
None listed