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

Launched by CENTRE OSCAR LAMBRET · Dec 9, 2024

Keywords

ClinConnect Summary

The FIMBRIMENOP-2402 study is a clinical trial designed to explore ways to lower the risk of ovarian and pelvic cancer in women who have certain genetic mutations, such as BRCA1 or BRCA2. This study compares two types of preventive surgery: one involves removing just a part of the fallopian tubes (called fimbriectomy) and then later removing the ovaries at menopause; the other involves removing both the ovaries and fallopian tubes at once (bilateral salpingo-oophorectomy). Women will have the chance to choose which surgery they prefer after receiving counseling about their genetic risks.

To participate, women need to be between 35 and 50 years old and have been identified as having a higher risk of developing cancer based on their genetic test results. Participants will be followed for many years to see how effective these surgeries are in reducing cancer risk. It’s important to note that this is the first study of its kind in France, and it aims to provide valuable information about the best ways to manage cancer risk for women with these genetic mutations.

Gender

FEMALE

Eligibility criteria

• 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