Evaluating a new surgical approach to reduce ovarian cancer risk in high-risk women
Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study
NA · M.D. Anderson Cancer Center · NCT05287451
This study is testing a new surgery to see if removing fallopian tubes now and delaying ovary removal later can help women with BRCA1/2 gene mutations lower their risk of ovarian cancer just as well as the usual surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Locations | 9 sites (Boston, Massachusetts and 8 other locations) |
| Trial ID | NCT05287451 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of risk-reducing salpingectomy with delayed oophorectomy as an alternative to the standard risk-reducing salpingo-oophorectomy in women with BRCA1/2 gene mutations. The research will focus on whether delaying oophorectomy until the ages of 40-45 for BRCA1 and 45-50 for BRCA2 can maintain a similar level of protection against high-grade serous ovarian cancer compared to the current standard procedure. Participants will be premenopausal women who have completed childbearing and have at least one fallopian tube. The study will also evaluate the incidence of (pre)malignant findings and other related health outcomes.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 25-50 with documented deleterious mutations in BRCA1, BRCA2, BRIP1, RAD51C, or RAD51D.
Not a fit: Patients who are postmenopausal or have a personal history of ovarian, fallopian tube, or peritoneal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow high-risk women to delay menopause while still effectively reducing their risk of ovarian cancer.
How similar studies have performed: Other studies have explored similar surgical approaches, but this specific method of delayed oophorectomy in high-risk women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation. 2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2 3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable 4. Presence of at least one fallopian tube 5. Participants may have a personal history of non-ovarian malignancy 6. Informed consent must be obtained and documented. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Postmenopausal status (natural menopause or due to (cancer) treatment) 2. Wish for second stage RRO within two years after RRS (if clear at enrollment) 3. Legally incapable 4. Prior bilateral salpingectomy 5. A personal history of ovarian, fallopian tube, or peritoneal cancer 6. Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
Where this trial is running
Boston, Massachusetts and 8 other locations
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- WU St Louis — St Louis, Missouri, United States (RECRUITING)
- Mount Sinai Health System — New York, New York, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Lyndon Baines Johnson General — Houston, Texas, United States (RECRUITING)
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- University of Washington — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Roni Wilke, MD — M.D. Anderson Cancer Center
- Study coordinator: Roni Wilke, MD
- Email: rnitecki@mdanderson.org
- Phone: (713) 822-4502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, Fallopian Tube Cancer