Radical Fimbriectomy for Young BRCA Mutation Carriers

BRCA1 Mutation Clinical Trial

— Fimbriectomy  

Official title:

Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01608074
• Other study ID #: FIMBRIECTOMIE
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2011
• Est. completion date: August 2033

Study information

• Verified date: June 2023
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 ovarian hormonal secretion.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome

Intervention

Procedure:
• Radical 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)

Other:
• Histopathology SEE-FIM
Anatomopathological study of surgical specimens

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Centre Oscar Lambret	CTD-CNO, Laboratoire PRISM

Country where clinical trial is conducted

France, 

Outcome

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