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Active, Not Recruiting

NCT Number: NCT01608074

Radical Fimbriectomy for Young BRCA Mutation Carriers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

BRCA1 Mutation Adnexal Diseases BRCA2 Mutation Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hereditary Breast and Ovarian Cancer Hereditary Breast and Ovarian Cancer Syndrome Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique du Parc Rambot, Aix-en-Provence, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radical fimbriectomy

Procedure

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

Other

Anatomopathological study of surgical specimens

Other names: Sectioning and Extensively Examining the FIMbria

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • CTD-CNO
  • Laboratoire PRISM

Registry information

Official study title

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

Acronym: FIMBRIECTOMIE

Important dates

Study start
2012
Primary completion
2033
Study completion
2033
First posted
May 30, 2012
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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