Status:
RECRUITING
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
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade ser...
Detailed Description
The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponem...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
- Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2
- No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable
- Presence of at least one fallopian tube
- Participants may have a personal history of non-ovarian malignancy
- Informed consent must be obtained and documented.
Exclusion
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Postmenopausal status (natural menopause or due to (cancer) treatment)
- Wish for second stage RRO within two years after RRS (if clear at enrollment)
- Legally incapable
- Prior bilateral salpingectomy
- A personal history of ovarian, fallopian tube, or peritoneal cancer
- Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 26 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05287451
Start Date
May 10 2022
End Date
December 26 2026
Last Update
November 5 2025
Active Locations (9)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
WU St Louis
St Louis, Missouri, United States, 63130
4
Mount Sinai Health System
New York, New York, United States, 10029