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.
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
- Conditions the study is for
- Tubo-ovarian Carcinoma, High-grade Serous Carcinoma, Primary Peritoneal Carcinoma Stage III
- 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.
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
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
- Fimbriectomy followed by delayed oophorectomy (F-DO).
- Bilateral salpingo-oophorectomy (BSO).
The primary objective is to compare the long-term efficacy of two preventive surgical strategies :
- Fimbriectomy followed by delayed oophorectomy (F-DO).
- 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:
- Annual Clinical Assessments: Participants undergo routine clinical evaluations, including physician visits, medical reports, and online questionnaires or phone interviews.
- Regional Oncogenetic Networks: Data from regional networks are incorporated to monitor oncological events and compliance.
- 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.
- Conditions
- Tubo-ovarian Carcinoma, High-grade Serous Carcinoma, Primary Peritoneal Carcinoma Stage III, Primary Peritoneal Carcinoma Stage IV, Primary Peritoneal Carcinoma
- 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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Bilateral Salpingo-Oophorectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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).
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)
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.
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.
- First posted10 Dec 2024
- Study startMar 2027 (estimated)
- Primary completionMar 2071 (estimated)
- Study completionMar 2071 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tubo-ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos MARTINEZ GOMEZ, MD, Study director, Centre Oscar LambretAudrey MAILLIEZ, MD, Study director, Centre Oscar Lambret
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06726330
- Acronym / sponsor ID
- FIMBRIMENOP / FIMBRIMENOP-2402
- Conditions
- Tubo-ovarian Carcinoma, High-grade Serous Carcinoma, Primary Peritoneal Carcinoma Stage III, Primary Peritoneal Carcinoma Stage IV, Primary Peritoneal Carcinoma
- Keywords
- Tubo-ovarian carcinoma, Primary peritoneal carcinoma, BRCA1/2 mutations, RAD51C/D mutations, PALB2 mutation, Preventive surgery, Fimbriectomy, Bilateral salpingo-oophorectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2071 (estimated)
- Study completion
- Mar 2071 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- Fimbriectomy followed by delayed oophorectomy (F-DO).
- Bilateral salpingo-oophorectomy (BSO).
The primary objective is to compare the long-term efficacy of two preventive surgical strategies :
- Fimbriectomy followed by delayed oophorectomy (F-DO).
- 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.
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:
- Annual Clinical Assessments: Participants undergo routine clinical evaluations, including physician visits, medical reports, and online questionnaires or phone interviews.
- Regional Oncogenetic Networks: Data from regional networks are incorporated to monitor oncological events and compliance.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fimbriectomy Followed by Delayed Oophorectomy (F-DO) | Experimental | Procedure: Fimbriectomy Followed by Delayed Oophorectomy (F-DO)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. |
| Bilateral Salpingo-Oophorectomy (BSO) | Active comparator | Procedure: Bilateral Salpingo-OophorectomyParticipants 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. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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"
Key exclusion criteria (9 listed)
- 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
- If prior hysterectomy: FSH >20 UI/L with low estrogen level (with or without vasomotor symptoms, genitourinary symptoms)
- Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fimbriectomy Followed by Delayed Oophorectomy (F-DO)Also: fimbriectomyThis 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 | Procedure or surgery | Fimbriectomy Followed by Delayed Oophorectomy (F-DO) |
| Bilateral Salpingo-OophorectomyAlso: BSOThis 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. | Procedure or surgery | Bilateral Salpingo-Oophorectomy (BSO) |
Primary outcome
Incidence of Advanced-Stage (Stage III or IV) Tubo-Ovarian or Primary Peritoneal Carcinoma
Time frame: Up to 70 years of age
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.
5 secondary outcomes
Incidence of Any-Stage Tubo-Ovarian or Primary Peritoneal Carcinoma
Time frame: Up to 70 years of age
Age at Menopause
Time frame: Over the study period (up to age 70).
Incidence of Cardiovascular Events and Osteoporosis-Related Events
Time frame: Over the study period (up to age 70)
Overall Survival
Time frame: From study entry to death from any cause.
Surgical Complications
Time frame: 30 days following the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Derived from this study: PubMed 42140840Schoenen 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos MARTINEZ GOMEZ, MD study director
Centre Oscar Lambret
Audrey MAILLIEZ, MD study director
Centre Oscar Lambret
23 sites in 1 country: see every site and its status.
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.