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Radical Fimbriectomy for Young BRCA Mutation Carriers (Fimbriectomy)

Primary Purpose

BRCA1 Mutation, BRCA2 Mutation, Hereditary Breast and Ovarian Cancer

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radical fimbriectomy
Histopathology SEE-FIM
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for BRCA1 Mutation focused on measuring BRCA1, BRCA2, Prophylactic surgery, Salpingectomy, Fimbriectomy

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Polyclinique du Parc Rambot
  • Institut Bergonié
  • Centre Jean Perrin
  • Centre Oscar Lambret
  • CHR-U
  • Clinique du Bois - Bourgogne Center
  • Hospices Civils de Lyon
  • Institut Paoli Calmettes
  • Centre Antoine Lacassagne
  • Institut Curie
  • Centre Henri Becquerel
  • IUCT-O Toulouse
  • Institut Gustave Roussy
  • Hôpital Privé VA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BRCA mutation carriers

Arm Description

Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM

Outcomes

Primary Outcome Measures

Rate of pelvic cancer
Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause

Secondary Outcome Measures

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
Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens
Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens
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
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
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
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
Proportion of benign histological abnormalities on radical Fimbriectomy specimens
Number of benign histological abnormalities on the operative specimens
Patient's satisfaction at distance from Radical Fimbriectomy
Patient satisfaction survey

Full Information

First Posted
May 15, 2012
Last Updated
June 30, 2023
Sponsor
Centre Oscar Lambret
Collaborators
CTD-CNO, Laboratoire PRISM
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1. Study Identification

Unique Protocol Identification Number
NCT01608074
Brief Title
Radical Fimbriectomy for Young BRCA Mutation Carriers
Acronym
Fimbriectomy
Official Title
Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2011 (Actual)
Primary Completion Date
August 2033 (Anticipated)
Study Completion Date
August 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
CTD-CNO, Laboratoire PRISM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BRCA1 Mutation, BRCA2 Mutation, Hereditary Breast and Ovarian Cancer
Keywords
BRCA1, BRCA2, Prophylactic surgery, Salpingectomy, Fimbriectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRCA mutation carriers
Arm Type
Experimental
Arm Description
Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM
Intervention Type
Procedure
Intervention Name(s)
Radical fimbriectomy
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Histopathology SEE-FIM
Other Intervention Name(s)
Sectioning and Extensively Examining the FIMbria
Intervention Description
Anatomopathological study of surgical specimens
Primary Outcome Measure Information:
Title
Rate of pelvic cancer
Description
Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause
Time Frame
an expected average of 15 years
Secondary Outcome Measure Information:
Title
Morbidity associated with the radical prophylactic fimbriectomy
Description
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
Time Frame
Up to 30 days after the surgery
Title
Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens
Description
Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens
Time Frame
Within 1 month after fimbriectomy, and within 1 month after oophorectomy
Title
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
Description
Number of cases of breast cancer or breast cancer recurrence observed
Time Frame
an expected average of 15 years
Title
Rate of secondary oophorectomies and associated morbidity, and reasons for oophorectomy if decided before the age of 50 et before menopausis
Description
Number of oophorectomies and time between fimbriectomy and oophorectomy Complications according to NCI-CTCAE v4.0 grading scale
Time Frame
an expected average of 15 years
Title
Proteomic profile of tissues from radical fimbriectomy
Description
Immunostaining is realised on sections of ovary portion, fimbriae and fallopian tubes, then tumoral zones are selected for spatially resolved gun microproteomic analysis
Time Frame
Up to 7 years after sample collection
Title
Proportion of menopausal women before oophorectomy or at the LPLV without oophorectomy, and rate patients who experienced early menopause (before the age of 40)
Description
Number of cases of menopausis an early menopausis observed
Time Frame
an expected average of 15 years
Title
Proportion of benign histological abnormalities on radical Fimbriectomy specimens
Description
Number of benign histological abnormalities on the operative specimens
Time Frame
Within 1 month after fimbriectomy
Title
Patient's satisfaction at distance from Radical Fimbriectomy
Description
Patient satisfaction survey
Time Frame
Up to 10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos MARTINEZ-GOMEZ, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polyclinique du Parc Rambot
City
Aix en Provence
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-ferrand
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
CHR-U
City
Lille
Country
France
Facility Name
Clinique du Bois - Bourgogne Center
City
Lille
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
Institut Curie
City
Paris
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
IUCT-O Toulouse
City
Toulouse
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Facility Name
Hôpital Privé VA
City
Villeneuve-d'Ascq
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Radical Fimbriectomy for Young BRCA Mutation Carriers

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