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New Two-Step surgery could spare High-Risk women from early menopause

NCT ID NCT06726330

Prevention Sponsor: Centre Oscar Lambret Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new two-step preventive surgery for women with gene mutations (like BRCA1) that raise their risk of ovarian cancer. Instead of removing both ovaries and fallopian tubes at once, the first step removes only the fimbria (the end of the fallopian tube), and the ovaries are removed later, around menopause. The goal is to reduce cancer risk while delaying menopause and its side effects. About 1,100 women in France will choose either this new approach or the standard surgery, and they will be followed until age 70.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fimbriectomy followed by delayed oophorectomy (F-DO) surgical procedure
What this could lead to
If successful, this could offer a less drastic preventive option for women at high genetic risk of ovarian cancer, preserving ovarian function longer and delaying menopause.
What could go wrong
This is a non-randomized study, so results may be less definitive. The procedure is still being tested for effectiveness, and there is a small risk that cancer could still develop before the delayed ovary removal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Mar 2071

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Woman between 35 to 50 years 2. Addressed to or followed in an oncogenetic counselling 3. 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. 4. Written informed consent 5. Patient covered by the French "Social Security" Exclusion Criteria: 1. Prior bilateral oophorectomy and/or bilateral salpingectomy for any reason (prophylactic surgery or other) 2. Personal history of ovarian, fallopian tube or primary peritoneal cancer 3. 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 4. Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons) 5. Patient under guardianship or curatorship

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Conditions

The condition(s) this trial relates to.

ovarian carcinoma primary peritoneal carcinoma serous adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High grade serous carcinoma Primary peritoneal carcinoma Primary peritoneal carcinoma stage III Primary peritoneal carcinoma stage IV Tubo-ovarian carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, France

  • Centre François Baclesse

    Caen, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Universitaire Dijon Bourgogne

    Dijon, France

  • Centre Hospitalier Universitaire de Lille

    Lille, France

  • Centre Hospitalier de Valenciennes

    Valenciennes, France, France

  • Centre Jean Perrin

    Clermont-Ferrand, France

  • Centre Léon Bérard

    Lyon, France, France

  • Centre Oscar Lambret

    Lille, France

  • Centre hospitalier universitaire Grenoble-Alpes

    Grenoble, France

  • Clinique du Bois

    Lille, France

  • Gustave Roussy

    Paris, France

  • Hôpital Institut CURIE

    Paris, France

  • Hôpital Simone Veil - CH de Troyes

    Troyes, France

  • Hôpital Tenon AP-HP

    Paris, France

  • Hôpital de Saint-Cloud

    Saint-Cloud, France

  • Hôpital de la Pitié Salpêtrière - AP-HP

    Paris, France

  • Hôpitaux Privés Rouennais

    Rouen, France

  • Institut Bergonié

    Bordeaux, France

  • Institut Godinot

    Reims, France

  • Institut Paoli-Calmettes

    Marseille, France

  • Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU

    Nantes, France

  • Institut universitaire du cancer de Toulouse

    Toulouse, France, France

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