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Tubo-ovarian CarcinomaFIMBRIMENOPNCT06726330

Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer

A study testing Fimbriectomy Followed by Delayed Oophorectomy (F-DO) and Bilateral Salpingo-Oophorectomy in people with Tubo-ovarian Carcinoma and High-grade Serous Carcinoma, run by Centre Oscar Lambret at 23 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

FIMBRIMENOP-2402 study aims to evaluate the long-term management of cancer risks in premenopausal women who have a genetic predisposition to tubo-ovarian or primary peritoneal carcinoma, such as mutations in BRCA1, BRCA2, RAD51C, RAD51D, or PALB2 genes. Read more about this study

Who is it for?
Ages 35 to 50 years, women only
What is being tested?
Fimbriectomy Followed by Delayed Oophorectomy (F-DO) and Bilateral Salpingo-Oophorectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,100 participants
Where
23 sitesFrance
Study dates
Mar 2027to Mar 2071
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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"

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marie VANSEYMORTIER, PharmaD contact

0320295918

promotion@o-lambret.fr

Fanny BEN OUNE contact

0320295918

promotion@o-lambret.fr

23 sites in 1 country

France23 sites

  • Institut Bergonié

    Bordeaux

    Frédéric GUYON, MD

    Virginie BUBIEN, MD

  • Centre François Baclesse

    Caen

    Roman ROUZIER, MD

    Pascaline BERTHET, MD

  • Centre Jean Perrin

    Clermont-Ferrand

    Caroline CORNOU, MD

    Mathilde GAY BELLILE, MD

  • Centre Hospitalier Universitaire Dijon Bourgogne

    Dijon

  • Centre hospitalier universitaire Grenoble-Alpes

    Grenoble

    Anne Cécile PHILIPPE, MD

    LEGRAND, MD

  • Centre Hospitalier Universitaire de Lille

    Lille

  • Centre Oscar Lambret

    Lille

    Pauline SMIS, +333 20 29 59 59, investigation@o-lambret.fr

    Carlos MARTINEZ GOMEZ, MD

  • Clinique du Bois

    Lille

    Jean Yves CHARVOLIN, MD

    Claude ADENIS, MD

  • Centre Léon Bérard

    Lyon, France

    Léa ROSSI, MD

    Pauline ROCHEFORT, MD

  • Institut Paoli-Calmettes

    Marseille

    Camille JAUFFRET, MD

    Catherine NOGUES, MD

  • Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU

    Nantes

    Célia CHALUMEAU, MD

    ABADIE Caroline, MD

  • Centre Antoine Lacassagne

    Nice

    Véronique MARI, MD

    Marie GOSSET, MD

  • Gustave Roussy

    Paris

  • Hôpital de la Pitié Salpêtrière - AP-HP

    Paris

    Catherine UZAN, MD

    Clémence EVREVIN, MD

  • Hôpital Institut CURIE

    Paris

    Virginie FOURCHOTTE, MD

    Chrystelle COLAS, MD

  • Hôpital Tenon AP-HP

    Paris

    Cyril TOUBOUL, MD

    Clémence EVREVIN, MD

  • Institut Godinot

    Reims

    Judicael HOTTON, MD

    Fanny BRAYOTEL, MD

  • Centre Henri Becquerel

    Rouen

    Agathe CROUZET, MD

    Jean Christophe TERY, MD

  • Hôpitaux Privés Rouennais

    Rouen

    Benoit RESCH, MD

    Jean Christophe TERY, MD

  • Hôpital de Saint-Cloud

    Saint-Cloud

    Claire BONNEAU, MD

    Emmanuelle MOURET-FOURME, MD

  • Institut universitaire du cancer de Toulouse

    Toulouse, France

    Gwenael FERRON, MD

    Laurence GLADIEFF, MD

  • Hôpital Simone Veil - CH de Troyes

    Troyes

  • Centre Hospitalier de Valenciennes

    Valenciennes, France

    Yves BORGHESI, MD

    Alfane BRAHIMI, MD

Other trials in France

About this study

Official title: Evaluation of Risk Control of Advanced Stage Tubo-ovarian or Primary Peritoneal Carcinoma Associated With Ovarian Carcinoma Risk-reducing Strategies, Including Fimbriectomy With Delayed Oophorectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer

  • FIMBRIMENOP-2402 study aims to evaluate the long-term management of cancer risks in premenopausal women who have a genetic predisposition to tubo-ovarian or primary peritoneal carcinoma, such as mutations in BRCA1, BRCA2, RAD51C, RAD51D, or PALB2 genes. This study offers an alternative to standard preventive surgery (bilateral salpingo-oophorectomy or BSO) by exploring the use of fimbriectomy (removal of the fallopian tube's fimbria) followed by delayed oophorectomy (removal of ovaries at menopause).

It's a pragmatic multicenter trial conducted across various medical centers, employing a non-randomized controlled preference design to compare two preventive surgical strategies:

Read more
  1. Fimbriectomy followed by delayed oophorectomy (F-DO).
  2. Bilateral salpingo-oophorectomy (BSO).

The primary objective is to compare the long-term efficacy of two preventive surgical strategies :

  1. Fimbriectomy followed by delayed oophorectomy (F-DO).
  2. Bilateral salpingo-oophorectomy (BSO).

As for the design of the study, participants choose their preferred surgical strategy during or after oncogenetic counseling, ensuring patient autonomy in decision-making.

  • 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.

Read the detailed description
  • The FIMBRIMENOP-2402 study is a pragmatic, multicenter, interventional trial (RIPH1) designed to evaluate long-term management strategies for reducing cancer risk in premenopausal women genetically predisposed to tubo-ovarian or primary peritoneal carcinoma. Women carrying mutations in BRCA1, BRCA2, RAD51C, RAD51D, or PALB2 genes are the primary focus of this investigation.
  • Objectives

The primary objective is to evaluate, on a long-term horizon, the control of the risk of advanced stage tubo-ovarian or primary peritoneal carcinoma according to the chosen care pathway, and more specifically whether F-DO is non inferior to BSO, in women with a germline mutation predisposing to the risk of high grade serous tubo-ovarian or primary peritoneal carcinoma.

The study aims to determine whether F-DO is non-inferior to BSO in controlling the risk of advanced-stage tubo-ovarian or primary peritoneal carcinoma in high-risk women.

The secondary objectives include evaluating the benefit-risk ratio of these approaches by assessing:

  • Menopause-related side effects, such as cardiovascular and osteoporosis-related events.
  • Surgical complications and overall survival.
  • Long-term oncological outcomes, including breast cancer risks.
  • Patient-reported preferences and compliance with the chosen pathway.

The study will also contribute to a prospective meta-analysis of similar international studies.

  • Design and Methodology

The study employs a non-randomized controlled preference design, allowing participants to choose their preventive surgical strategy after informed counseling with oncogeneticists and gynecologic surgeons. This approach promotes patient autonomy while reflecting real-world clinical decision-making. Participants may revise their choice at any time before the first surgical intervention. The actual treatment received or the final preference will define the "care pathway".

  • Population and Recruitment

The study will enroll 1,100 premenopausal women aged 35-50 years from multiple French centers, all of whom are at an elevated genetic risk for tubo-ovarian or primary peritoneal carcinoma. Recruitment is expected to span five years, with follow-up continuing until participants reach 70 years of age.

  • Data Collection and Follow-Up

Data collection integrates multiple sources to ensure comprehensive coverage of outcomes:

  1. Annual Clinical Assessments: Participants undergo routine clinical evaluations, including physician visits, medical reports, and online questionnaires or phone interviews.
  2. Regional Oncogenetic Networks: Data from regional networks are incorporated to monitor oncological events and compliance.
  3. French Administrative Health Database (SNDS): Extraction of anonymized health records ensures the completeness of reported events and reduces logistical complexity.
  • Endpoints :
  • Primary Endpoint :

The incidence of advanced-stage (stage III or IV) tubo-ovarian or primary peritoneal carcinoma, measured as the time from study entry to the occurrence of cancer, with death without cancer as a competing event. Censoring will occur at the last follow-up visit for women without cancer.

  • Secondary Endpoints include :
  • Incidence of tubo-ovarian carcinoma at any stage, breast cancer, cardiovascular and osteoporosis-related events.
  • Age at menopause.
  • Surgical complications within 30 days post-surgery, graded per NCI-CTCAE V5.0.
  • Statistical Analysis

The final analysis will occur when all participants have been followed for 35 years, with interim analyses planned every six years or upon reporting of 10 events. Data will be analyzed to compare oncological outcomes, quality of life, and survival between the F-DO and BSO groups. Biases inherent in the preference design will be addressed through appropriate statistical modeling.

  • Ethical Considerations

The study adheres to French regulatory requirements, including patient data confidentiality under the GDPR and ethical review by relevant committees. Informed consent will be obtained from all participants, with clear communication of risks and benefits.

By evaluating the efficacy and safety of F-DO, this study has the potential to redefine preventive surgical strategies, optimizing outcomes for women at high genetic risk of ovarian cancer.

Being tested
Fimbriectomy Followed by Delayed Oophorectomy (F-DO), Bilateral Salpingo-Oophorectomy
Keywords
Tubo-ovarian carcinoma, Primary peritoneal carcinoma, BRCA1/2 mutations, RAD51C/D mutations, PALB2 mutation, Preventive surgery, Fimbriectomy, Bilateral salpingo-oophorectomy, BSO, Cancer prevention, Premenopausal women, Genetic predisposition to cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fimbriectomy Followed by Delayed Oophorectomy (F-DO)Procedure or surgery

    Also called fimbriectomy

    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

  • Bilateral Salpingo-OophorectomyProcedure or surgery

    Also called BSO

    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.

Study groups in NCT06726330
Study groupRoleWhat they receive
Fimbriectomy Followed by Delayed Oophorectomy (F-DO)ExperimentalParticipants 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.
Receives: Procedure: Fimbriectomy Followed by Delayed Oophorectomy (F-DO)
Bilateral Salpingo-Oophorectomy (BSO)Active comparatorParticipants 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.
Receives: Procedure: Bilateral Salpingo-Oophorectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 70 years of age

Secondary outcomes (5)

  1. Incidence of Any-Stage Tubo-Ovarian or Primary Peritoneal Carcinoma

    Time from study entry to diagnosis of any stage of tubo-ovarian or primary peritoneal carcinoma, including pre-invasive lesions such as serous tubal intraepithelial carcinoma (STIC).

    Measured: Up to 70 years of age

  2. Age at Menopause

    The age at menopause will be determined through clinical assessments, hormone level measurements, and patient-reported outcomes. Criteria include cessation of menses for at least 12 months in non-hysterectomized women or FSH levels >20 UI/L with low estrogen levels.

    Measured: Over the study period (up to age 70).

  3. Incidence of Cardiovascular Events and Osteoporosis-Related Events

    Long-term cardiovascular (e.g., myocardial infarction, stroke) and osteoporosis-related events (e.g., hip fractures) will be recorded from clinical evaluations and the SNDS database.

    Measured: Over the study period (up to age 70)

  4. Overall Survival

    Overall survival will be tracked using clinical data, SNDS records, and vital status updates.

    Measured: From study entry to death from any cause.

  5. Surgical Complications

    Complications will be graded using the NCI-CTCAE v5.0 system and classified as related to surgery. Severe adverse events (grade 3+) and serious adverse events will be reported.

    Measured: 30 days following the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study startMar 2027 (estimated)
  3. Primary completionMar 2071 (estimated)
  4. Study completionMar 2071 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06726330
Sponsor's protocol ID
FIMBRIMENOP-2402
Other IDs
PHRC-K24-013, 2024-A01760-47
Acronym
FIMBRIMENOP
Status last verified
Mar 2026
First submitted
25 Nov 2024
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Schoenen S, Mailliez A, Risbourg S, Decoupigny E, Vanseymortier M, Pasquesoone C, Le Saux O, Ray-Coquard I, Navarro AS, Bresson L, Thiebaut A, Antoni G, Bertrand N, Leblanc E, Narducci F, Le Deley MC, Martinez Gomez C. FIMBRIMENOP-2402 trial: evaluating fimbriectomy with delayed oophorectomy in patients with high-risk tubo-ovarian cancer. Int J Gynecol Cancer. 2026 Apr 18:104715. doi: 10.1016/j.ijgc.2026.104715. Online ahead of print.

    PubMed 42140840

Questions about this trial

What is this clinical trial studying?

A study testing Fimbriectomy Followed by Delayed Oophorectomy (F-DO) and Bilateral Salpingo-Oophorectomy in people with Tubo-ovarian Carcinoma and High-grade Serous Carcinoma, run by Centre Oscar Lambret at 23 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie VANSEYMORTIER, PharmaD (0320295918, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Advanced-Stage (Stage III or IV) Tubo-Ovarian or Primary Peritoneal Carcinoma (time frame: Up to 70 years of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06726330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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