BRCA1 Mutation Clinical Trial
— FimbriectomyOfficial title:
Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma
Verified date | June 2023 |
Source | Centre Oscar Lambret |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 123 |
Est. completion date | August 2033 |
Est. primary completion date | August 2033 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | 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 |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret | CTD-CNO, Laboratoire PRISM |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of pelvic cancer | Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause | an expected average of 15 years | |
Secondary | 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 | Up to 30 days after the surgery | |
Secondary | Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens | Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens | Within 1 month after fimbriectomy, and within 1 month after oophorectomy | |
Secondary | 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 | an expected average of 15 years | |
Secondary | 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 | an expected average of 15 years | |
Secondary | 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 | Up to 7 years after sample collection | |
Secondary | 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 | an expected average of 15 years | |
Secondary | Proportion of benign histological abnormalities on radical Fimbriectomy specimens | Number of benign histological abnormalities on the operative specimens | Within 1 month after fimbriectomy | |
Secondary | Patient's satisfaction at distance from Radical Fimbriectomy | Patient satisfaction survey | Up to 10 years |
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