CC008 A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]
ClinicalTrials.gov NCT # 04251052
This trial is part of the Community Oncology Research Program (NCORP), which is sponsored by the National Cancer Institute (NCI).
Purpose:
The main purpose of this study is to determine if two surgical procedures, the usual approach of removing the fallopian tubes and ovaries and the other approach of removing the fallopian tubes at this time with the plan to remove the ovaries at a later time, are no different for ovarian cancer risk reduction in women with BRCA1 mutations who have completed childbearing. In this study, the removal of fallopian tubes will be compared to the removal of fallopian tubes and ovaries. The study will also examine what factors go into deciding which surgery to have and symptoms after surgery caused by lack of estrogen due to ovary removal.
Treatment Arms (Selected by patient):
- Experimental Care--Bilateral Salpingectomy (removal of fallopian tubes only)
- Standard Care--Bilateral Salpingo-Oophorectomy (removal of both ovaries and fallopian tubes).
Follow-Up:
Follow-up for 5 years.
Eligibility Criteria:
- Women with BRCA1+ mutation
- Women must be between 35-50 years of age
For additional information, please contact the Research Nurses:
- Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
- Susan Metzger, RN, MSN; 610-738-2515