Salpingectomy versus Salping-Oophorectomy to Reduce Risk of Ovarian Cancer in Women with BRCA1 Mutations (SOROCk)

This trial is to compare bilateral fallopian tube removal versus bilateral fallopian tube and ovary removal to reduce the risk of developing ovarian cancer in women with BRCA1 mutations.

About

Protocol Description

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

Eligibility Criteria

Inclusion Criteria

  • Women 35-50 years of age
  • At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy only is allowed; prior tubal ligation is allowed if one intact ovary and tube are present.
  • Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself
  • Transvaginal ultrasound and CA-125 within 180 days of registration

Exclusion Criteria

  • Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy within the past 90 days or radiotherapy to the abdomen or pelvis at any prior time
  • Prior history of ovarian cancer, including low malignant potential neoplasms, primary peritoneal carcinoma or fallopian tube carcinoma
  • Patients medically deemed unfit for the planned surgical procedure
  • Patients with an abnormal transvaginal ultrasound or CA-125 that is suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days
  • Women who are currently pregnant or plan to become pregnant in the future

Primary Investigator

Dr. Janet Osborne is a Gynecologic Oncologist with more than two decades of clinical and research experience. She is board certified by the American Board of Obstetrics and Gynecology in Gynecologic Oncology. She completed her fellowship at the University of Michigan and her internship and residency at the University of Minnesota Hospital and Clinics.

Contact Information

Amuktha Polkampally, PharmD
Clinical Research Coordinator
Carilion Clinic GYN/Oncology