About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Postmenopausal status (natural menopause or due to treatment)
Wish for second stage RRO within two years after RRS
Legally incapable
Prior bilateral salpingectomy
Trial design
Parallel
Treatments tested in this trial
Risk-reducing salpingectomy with delayed oophorectomy
Procedure/Surgery* 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)
Risk-reducing salpingo-oophorectomy
Procedure/Surgery* 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)
Treatment groups
Trial outcomes
Primary outcomes
High grade serous (ovarian) cancer incidence
High grade serous (ovarian) cancer incidence
Secondary outcomes
Incidence of (pre)malignant findings in tubes/ovaries
Incidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.
Peri-operative morbidity and mortality
Peri-operative morbidity and mortality
Incidence of pelvic cancer (other than ovarian cancer)
Incidence of pelvic cancer (other than ovarian cancer)
Incidence of breast cancer
Incidence of breast cancer
Other outcomes
High grade serous (ovarian) cancer incidence at the age of 70
Exploratory outcome measure
Sponsors and contacts
Click on the lead sponsor to view all of their trials.