Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer
NCT ID: NCT06726330
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1100 participants
INTERVENTIONAL
2025-03-31
2065-03-31
Brief Summary
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It's a pragmatic multicenter trial conducted across various medical centers, employing a non-randomized controlled preference design to compare two preventive surgical strategies:
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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Fimbriectomy Followed by Delayed Oophorectomy (F-DO)
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-Oophorectomy (BSO)
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.
Bilateral Salpingo-Oophorectomy
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.
Interventions
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Fimbriectomy Followed by Delayed Oophorectomy (F-DO)
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-Oophorectomy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
35 Years
50 Years
FEMALE
No
Sponsors
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Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Carlos MARTINEZ GOMEZ, MD
Role: STUDY_DIRECTOR
Centre Oscar Lambret
Audrey MAILLIEZ, MD
Role: STUDY_DIRECTOR
Centre Oscar Lambret
Locations
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Institut Bergonié
Bordeaux, , France
Centre François Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon, , France
Centre hospitalier universitaire Grenoble-Alpes
Grenoble, , France
Centre Hospitalier Universitaire de Lille
Lille, , France
Centre Oscar Lambret
Lille, , France
Clinique du Bois
Lille, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Gustave Roussy
Paris, , France
Hôpital de la Pitié Salpêtrière - AP-HP
Paris, , France
Hôpital Institut CURIE
Paris, , France
Hôpital Tenon AP-HP
Paris, , France
Institut Godinot
Reims, , France
Centre Henri Becquerel
Rouen, , France
Hôpitaux Privés Rouennais
Rouen, , France
Hôpital de Saint-Cloud
Saint-Cloud, , France
Institut universitaire du cancer de Toulouse
Toulouse, , France
Hôpital Simone Veil - CH de Troyes
Troyes, , France
Centre Hospitalier de Valenciennes
Valenciennes, , France
Countries
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Central Contacts
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Facility Contacts
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Pauline SMIS
Role: primary
Other Identifiers
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PHRC-K24-013
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-A01760-47
Identifier Type: OTHER
Identifier Source: secondary_id
FIMBRIMENOP-2402
Identifier Type: -
Identifier Source: org_study_id