A Study to Compare Two Surgical Procedures in Women with BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer (SOROCk)

About the study

SOROCk [NRG-CC008] is a clinical trial studying if removal of just the fallopian tubes can reduce the risk of ovarian cancer nearly as much as removing both the ovaries and fallopian tubes among women with an inherited BRCA1 mutation. The main benefit of removing only the fallopian tubes and not the ovaries is to prevent surgically-induced menopause. The study will also examine various patient-reported quality of life outcomes. Researchers believe that most ovarian cancers first begin in the fallopian tubes, suggesting that removing the fallopian tubes only may prevent the development of ovarian cancer. This concept has never been formally testing in a clinical trial.

For more information, visit https://clinicaltrials.gov/show/NCT04251052. 

What the Study Entails

Here are the steps to participate in the SOROCk Study:

• Plan for ovarian cancer surgical risk reduction with either:
  • Standard of care surgery to remove both ovaries and fallopian tubes
  • Investigational surgery to remove only the fallopian tubes with a plan to remove the ovaries at a later time
  • Completing personal and family history questionnaires
  • Have recently had a normal pelvic ultrasound and a normal CA125 blood test
  • Give consent: This step includes:
  • Reading and signing the consent form to enroll
• Genetic testing
  • All participants must have an inherited mutation in BRCA1
• Get test results
  • Give a copy of your genetic test results from your surgeon.
• Follow up
  • Follow-up visits will occur after surgery and then once per year for approximately 6 to 16 years. These visits can be done with your surgeon or a local healthcare provider
  • All participants will be asked to complete an annual questionnaire for up to 20 years after the study. These can be completed electronically on an iPhone or similar device.

Study Lead Investigator

Warner Huh, MD
University of Alabama, Birmingham

Women can participate if:

• they are aged 35 to 50
• have an inherited mutation in BRCA1
• are planning to have surgery to reduce the risk of ovarian cancer
• are premenopausal or menopausal
• have at least one ovary and fallopian tube

People are excluded if they:

• have had prior cancer and received chemotherapy within the past 30 days. People who are receiving maintenance HER2 therapy (trastuzumab, pertuzumab) or hormonal therapy may still participate.
• have received radiotherapy to abdomen or pelvis at any time
• have a history of ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma
• cannot tolerate surgery or general anesthesia
• desire to become pregnant in the future. People who plan to become pregnant through assisted reproductive technologies such as in-vitro fertilization (IVF) may still participate.