NCT06726330

Brief Summary

  1. 1.Fimbriectomy followed by delayed oophorectomy (F-DO).
  2. 2.Bilateral salpingo-oophorectomy (BSO).
  3. 3.Fimbriectomy followed by delayed oophorectomy (F-DO).
  4. 4.Bilateral salpingo-oophorectomy (BSO).
  5. 5.Follow-Up: Long-term follow-up includes clinical assessments, data collection from medical networks, and integration with national health databases to track outcomes up to the age of 70. This is the first French comparative study in real-world settings and is classified as interventional research (RIPH1) under French regulations, given the need to validate fimbriectomy efficacy.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
536mo left

Started Mar 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

23 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
44 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2071

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2071

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

44 years

First QC Date

November 25, 2024

Last Update Submit

March 16, 2026

Conditions

Tubo-ovarian CarcinomaHigh-grade Serous CarcinomaPrimary Peritoneal Carcinoma Stage IIIPrimary Peritoneal Carcinoma Stage IVPrimary Peritoneal Carcinoma

Keywords

Tubo-ovarian carcinomaPrimary peritoneal carcinomaBRCA1/2 mutationsRAD51C/D mutationsPALB2 mutationPreventive surgeryFimbriectomyBilateral salpingo-oophorectomyBSOCancer preventionPremenopausal womenGenetic predisposition to cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of Advanced-Stage (Stage III or IV) Tubo-Ovarian or Primary Peritoneal Carcinoma

    The study evaluates the long-term incidence of advanced-stage (Stage III or IV) tubo-ovarian or primary peritoneal carcinoma. This measure will be assessed using annual clinical evaluations, patient questionnaires, medical records, and data extracted from the French National Health Database (SNDS) and regional oncogenetic networks. Time from study entry to cancer diagnosis will be calculated, with death without cancer considered as a competing event. Data will be censored at the last follow-up visit for participants alive without cancer.

    Up to 70 years of age

Secondary Outcomes (5)

  • Incidence of Any-Stage Tubo-Ovarian or Primary Peritoneal Carcinoma

    Up to 70 years of age

  • Age at Menopause

    Over the study period (up to age 70).

  • Incidence of Cardiovascular Events and Osteoporosis-Related Events

    Over the study period (up to age 70)

  • Overall Survival

    From study entry to death from any cause.

  • Surgical Complications

    30 days following the surgery

Other Outcomes (1)

  • Benefit-Risk Ratio Analysis

    Over the study period (up to age 70)

Study Arms (2)

Fimbriectomy Followed by Delayed Oophorectomy (F-DO)

EXPERIMENTAL

Participants in this arm will undergo fimbriectomy, a surgical procedure to remove the fimbrial end of the fallopian tubes, while preserving ovarian function. A delayed oophorectomy (removal of the ovaries) will be performed at menopause or later, based on individual timing and preferences. This approach aims to reduce the risk of advanced-stage tubo-ovarian or primary peritoneal carcinoma while minimizing the adverse effects of premature menopause.

Procedure: Fimbriectomy Followed by Delayed Oophorectomy (F-DO)

Bilateral Salpingo-Oophorectomy (BSO)

ACTIVE COMPARATOR

Participants in this arm will undergo a bilateral salpingo-oophorectomy (BSO), the standard preventive surgical strategy, involving the removal of both fallopian tubes and ovaries. This procedure is performed around the recommended age of 40-45 years for women with BRCA1/2 mutations or similar high-risk genetic predispositions. The primary objective is to eliminate the risk of tubo-ovarian or primary peritoneal carcinoma, though it induces premature menopause.

Procedure: Bilateral Salpingo-Oophorectomy

Interventions

Fimbriectomy Followed by Delayed Oophorectomy (F-DO)PROCEDURE

This intervention involves two stages: 1. Fimbriectomy: A preventive surgical procedure that removes the fimbrial end of the fallopian tubes, including adjacent ovarian tissue, while preserving ovarian function to avoid premature menopause. 2. Delayed Oophorectomy: The removal of ovaries, performed at menopause or later, depending on patient preference and clinical guidelines. * The F-DO strategy aims to reduce the risk of tubo-ovarian or primary peritoneal carcinoma, which often originates in the fallopian tubes, while minimizing the adverse effects of premature menopause such as cardiovascular disease and osteoporosis

Also known as: fimbriectomy
Fimbriectomy Followed by Delayed Oophorectomy (F-DO)
Bilateral Salpingo-OophorectomyPROCEDURE

This standard surgical intervention involves the removal of both fallopian tubes and ovaries (BSO) to eliminate the risk of tubo-ovarian or primary peritoneal carcinoma. It is typically recommended for women with a genetic predisposition (e.g., BRCA1/2 mutations) around the age of 40-45. While highly effective in preventing cancer, BSO induces premature menopause, which may result in long-term side effects such as increased cardiovascular risk, osteoporosis, and cognitive decline.

Also known as: BSO
Bilateral Salpingo-Oophorectomy (BSO)

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Woman between 35 to 50 years
  • Addressed to or followed in an oncogenetic counselling
  • Identified risk of tubo-ovarian or primary peritoneal carcinoma based on mutational status (BRCA1, BRCA 2, RAD51C, RAD51D, PALB2). The list of considered mutations may be extended during the study.
  • Written informed consent
  • Patient covered by the French "Social Security"

You may not qualify if:

  • Prior bilateral oophorectomy and/or bilateral salpingectomy for any reason (prophylactic surgery or other)
  • Personal history of ovarian, fallopian tube or primary peritoneal cancer
  • Menopause defined by
  • In women without prior chemotherapy If no prior hysterectomy: the absence of menses for at least 12 months, or FSH \> 20 UI/L with low estrogen level with no identified gynecological or endocrine explanation. Amenorrhea related to an intrauterine device, vaginal ring or estrogen-progestin pill will not be considered as menopause.
  • If prior hysterectomy: FSH \>20 UI/L with low estrogen level (with or without vasomotor symptoms, genitourinary symptoms)
  • In women with prior chemotherapy: the absence of menses for at least 24 months
  • In all women with progesterone-loaded intra-uterine device (IUD): FSH \> 20 UI/L with low estrogen level
  • Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)
  • Patient under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Centre Léon Bérard

Lyon, France, France

Location

Institut universitaire du cancer de Toulouse

Toulouse, France, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, France, France

Location

Institut Bergonié

Bordeaux, France

Location

Centre François Baclesse

Caen, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Centre Hospitalier Universitaire Dijon Bourgogne

Dijon, France

Location

Centre hospitalier universitaire Grenoble-Alpes

Grenoble, France

Location

Centre Hospitalier Universitaire de Lille

Lille, France

Location

Centre Oscar Lambret

Lille, France

Location

Clinique du Bois

Lille, France

Location

Institut Paoli-Calmettes

Marseille, France

Location

Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Gustave Roussy

Paris, France

Location

Hôpital de la Pitié Salpêtrière - AP-HP

Paris, France

Location

Hôpital Institut CURIE

Paris, France

Location

Hôpital Tenon AP-HP

Paris, France

Location

Institut Godinot

Reims, France

Location

Centre Henri Becquerel

Rouen, France

Location

Hôpitaux Privés Rouennais

Rouen, France

Location

Hôpital de Saint-Cloud

Saint-Cloud, France

Location

Hôpital Simone Veil - CH de Troyes

Troyes, France

Location

MeSH Terms

Interventions

Sterilization, Tubal

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativeSterilization, Reproductive

Study Officials

  • Carlos MARTINEZ GOMEZ, MD

    Centre Oscar Lambret

    STUDY DIRECTOR

  • Audrey MAILLIEZ, MD

    Centre Oscar Lambret

    STUDY DIRECTOR

Central Study Contacts

Marie VANSEYMORTIER, PharmaD

CONTACT

0320295918promotion@o-lambret.fr

Fanny BEN OUNE

CONTACT

0320295918promotion@o-lambret.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a non-randomized controlled preference trial. Participants decide their surgical approach based on counseling. The study accommodates real-world clinical practices, empowering patients in the decision-making process.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 10, 2024

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

March 1, 2071

Study Completion (Estimated)

March 1, 2071

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations

FR(23)