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
- Conditions
- Fallopian Tube CancerOvarian Cancer
- Registration Number
- NCT05287451
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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 serous (ovarian) cancer incidence
- 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 postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk.
PRIMARY OBJECTIVE:
To evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.
SECONDARY OBJECTIVE:
Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy.
EXPLORATORY OBJECTIVE:
Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers. through study completion, an average of 15 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
WU St Louis
🇺🇸St Louis, Missouri, United States
Mount Sinai Health System
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Lyndon Baines Johnson General
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
Dana Farber Cancer Institute🇺🇸Boston, Massachusetts, United StatesColleen FeltmatePrincipal Investigator