Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in France / NCT01608074
Active, not recruiting Not applicable

Radical Fimbriectomy for Young BRCA Mutation Carriers

NCT01608074 · tracked via the Priya Life Science France tracker
Sponsor
Centre Oscar Lambret
Phase
Not applicable
Started
2012-01-09
Last updated
2026-03-18

Condition(s) studied

BRCA1 MutationBRCA2 MutationHereditary Breast and Ovarian Cancer

Investigational drug(s) / intervention(s)

Radical fimbriectomyHistopathology SEE-FIM

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)

Histopathology SEE-FIM: Anatomopathological study of surgical specimens

Study 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.

Eligibility

Sex
FEMALE
Min age
35 Years
Max age
—
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

Primary outcome measure(s)

  • Rate of pelvic cancer — an expected average of 15 years
    Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause

Trial sites (14)

FacilityCityRegionStatus
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 France

More Centre Oscar Lambret trials in France

Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions Recruiting
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer Active, not recruiting
Benefits of Early Collaboration Between Oncologists and Palliative Care Physicians in Cases of Unplanned Hospitalization for Patients With Metastatic Cancer Starting soon
Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer Active, not recruiting
Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906) Recruiting

Other trials for the same condition

Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening Active, not recruiting
Investigation of Tumour Spectrum of Germline Mutations in Breast and Ovarian Cancer Genes. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01608074 on ClinicalTrials.gov ↗ ← All trials in France