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.
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 years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,000
* 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)
* 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)
Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGMD Anderson Cancer Centre
Houston, Texas, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
High grade serous (ovarian) cancer incidence
High grade serous (ovarian) cancer incidence
Time frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
Incidence of (pre)malignant findings in tubes/ovaries
Incidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.
Time frame: 6 weeks after each surgery
Peri-operative morbidity and mortality
Peri-operative morbidity and mortality
Time frame: 6 weeks after each surgery
Incidence of pelvic cancer (other than ovarian cancer)
Incidence of pelvic cancer (other than ovarian cancer)
Time frame: Up to the age of 70
Incidence of breast cancer
Incidence of breast cancer
Time frame: Up to the age of 70
Uptake of risk reducing oophorectomy
Uptake of risk reducing oophorectomy after risk reducing salpingectomy
Time frame: Up to the age of 70
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Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
RECRUITINGWestmead hospital
Sydney, New South Wales, Australia
RECRUITINGSt Andrew War Memorial Hospital
Brisbane, Queensland, Australia
RECRUITINGRoyal Brisbane Hospital
Brisbane, Queensland, Australia
RECRUITINGGreenslopes Private Hospital
Brisbane, Queensland, Australia
RECRUITINGRoyal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITING...and 38 more locations