TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.
University Medical Center Nijmegen
Summary
The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.
Description
In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last year…
Eligibility
- Age range
- 25–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers. * Age at inclusion; * BRCA1: 25-40 years * BRCA2: 25-45 years * RAD51C, RAD51D, BRIP1: 25-50 years * Childbearing completed * Presence of at least one fallopian tube * Participants may have a personal history of non-ovarian malignancy * Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution. Exclusion Criteria: * Postmenopausal st…
Interventions
- ProcedureRisk-reducing salpingectomy with delayed oophorectomy
* BRCA1: RRS at age 25-40 and RRO at a maximum age of 45 (advised between 35 and 45). * BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 40 and 50). * BRIP1, RAD51C, RAD51D: RRS at age 25-50 and RRO at a maximum age of 55 (advised between 45 and 55)
- ProcedureRisk-reducing salpingo-oophorectomy
* BRCA1 at a maximum age of 40 (advised between age 35 and 40) * BRCA2 at a maximum age of 45 (advised between age 40 and 45) * BRIP1, RAD51C, RAD51D: at a maximum age of 50 (advised between 45 and 50)
Locations (66)
- UChicago MedicineChicago, Illinois
- Dana Farber Cancer InstituteBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- Washington University Medical CenterSt Louis, Missouri
- Mount Sinai HospitalNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York