NRG-CC008: Ovarian Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare two surgical procedures. We want to know if one procedure is better than the other in terms of lowering the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.

What is the Condition Being Studied?

Ovarian Cancer

Who Can Participate in the Study?

Women ages 35-50 who:

  • Have a positive test for BRCA1 mutations
  • Have at least one intact ovary and one intact fallopian tube

For more information about who can join this study, please contact the study team at taylor.hayes@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:

  • Participants in Group 1 (BLS Group) will have surgery to remove the fallopian tubes and then have a second surgery later to remove the ovaries
  • Participants in Group 2 (BSO Group) will have surgery to remove the fallopian tubes and ovaries at the same time

Study Details

Full Title
NRG-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] (NCT # 04251052)
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00111375
NCT: NCT04251052
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment