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
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.
The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation.
No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.
Postmenopausal status (natural menopause or due to (cancer) treatment)
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can be considered.
Wish for second stage RRO within two years after RRS (if clear at enrollment)
Parallel
RIsk-Reducing Salpingectomy (RRS)
Other interventioncomplete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
Risk-Reducing Oophorectomy-RRO
Other interventioncomplete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
Risk-Reducing Salpingo-Oophorectomy-RRSO
Other interventioncomplete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
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.
Click on the lead sponsor to view all of their trials.
