Clinical trial NCT01608074: Radical Fimbriectomy for Young BRCA Mutation Carriers
Official title: Radical Fimbriectomy for Young BRCA Mutation Carriers At Risk of Pelvic Serous Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: BRCA1 Mutation
BRCA2 Mutation
Hereditary Breast and Ovarian Cancer
Keywords: BRCA1
BRCA2
Prophylactic surgery
Salpingectomy
Fimbriectomy
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: CTD-CNO
name: Laboratoire PRISM
First posted: 2012-05-30
Enrollment: 123
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of pelvic cancer
timeFrame: an expected average of 15 years
Secondary outcomes:
measure: Morbidity associated with the radical prophylactic fimbriectomy
timeFrame: Up to 30 days after the surgery
measure: Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens
timeFrame: Within 1 month after fimbriectomy, and within 1 month after oophorectomy
measure: 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
timeFrame: an expected average of 15 years
measure: Rate of secondary oophorectomies and associated morbidity, and reasons for oophorectomy if decided before the age of 50 et before menopausis
timeFrame: an expected average of 15 years
measure: Proteomic profile of tissues from radical fimbriectomy
timeFrame: Up to 7 years after sample collection
measure: Proportion of menopausal women before oophorectomy or at the LPLV without oophorectomy, and rate patients who experienced early menopause (before the age of 40)
timeFrame: an expected average of 15 years
measure: Proportion of benign histological abnormalities on radical Fimbriectomy specimens
timeFrame: Within 1 month after fimbriectomy
measure: Patient's satisfaction at distance from Radical Fimbriectomy
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Polyclinique du Parc Rambot
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHR-U
city: Lille
country: France
facility: Clinique du Bois - Bourgogne Center
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Toulouse
country: France
facility: IUCT-O Toulouse
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villeneuve-d'Ascq
country: France
facility: Hôpital Privé VA
Study officials:
affiliation: Centre Oscar Lambret
name: Carlos MARTINEZ-GOMEZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Leblanc 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.