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Radical Fimbriectomy for Young BRCA Mutation Carriers (Fimbriectomy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01608074
Recruitment Status : Active, not recruiting
First Posted : May 30, 2012
Last Update Posted : June 2, 2022
Sponsor:
Collaborators:
CTD-CNO
Laboratoire PRISM
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease Intervention/treatment Phase
BRCA1 Mutation BRCA2 Mutation Hereditary Breast and Ovarian Cancer Procedure: Radical fimbriectomy Other: Histopathology SEE-FIM Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma
Actual Study Start Date : December 2011
Actual Primary Completion Date : December 2019
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BRCA mutation carriers

Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer.

Radical fimbriectomy. Histopathology SEE-FIM

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
Other Name: Sectioning and Extensively Examining the FIMbria




Primary Outcome Measures :
  1. Rate of pelvic cancer [ Time Frame: an expected average of 15 years ]
    Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause


Secondary Outcome Measures :
  1. Morbidity associated with the radical prophylactic fimbriectomy [ Time Frame: 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

  2. Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens [ Time Frame: Within 1 month after fimbriectomy, and within 1 month after oophorectomy ]
    Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens

  3. 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 [ Time Frame: an expected average of 15 years ]
    Number of cases of breast cancer or breast cancer recurrence observed

  4. Rate of secondary oophorectomies and associated morbidity, and reasons for oophorectomy if decided before the age of 50 et before menopausis [ Time Frame: an expected average of 15 years ]
    Number of oophorectomies and time between fimbriectomy and oophorectomy Complications according to NCI-CTCAE v4.0 grading scale

  5. Proteomic profile of tissues from radical fimbriectomy [ Time Frame: 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

  6. Proportion of menopausal women before oophorectomy or at the LPLV without oophorectomy, and rate patients who experienced early menopause (before the age of 40) [ Time Frame: an expected average of 15 years ]
    Number of cases of menopausis an early menopausis observed

  7. Proportion of benign histological abnormalities on radical Fimbriectomy specimens [ Time Frame: Within 1 month after fimbriectomy ]
    Number of benign histological abnormalities on the operative specimens

  8. Patient's satisfaction at distance from Radical Fimbriectomy [ Time Frame: Up to 10 years ]
    Patient satisfaction survey



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608074


Locations
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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, France
Sponsors and Collaborators
Centre Oscar Lambret
CTD-CNO
Laboratoire PRISM
Investigators
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Principal Investigator: Carlos MARTINEZ-GOMEZ, MD Centre Oscar Lambret
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01608074    
Other Study ID Numbers: FIMBRIECTOMIE
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Oscar Lambret:
BRCA1
BRCA2
Prophylactic surgery
Salpingectomy
Fimbriectomy
Additional relevant MeSH terms:
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Hereditary Breast and Ovarian Cancer Syndrome
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases