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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)

Objective

To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germline mutations.

Protocol #

NRG-CC008

Trial Phase:

Phase N/A

Principal Investigator:

Salyer, Chelsea

Cancer Type
  • Other Female Genital
  • Ovary
Study Site
  • Carilion Medical Center
  • Stony Point
  • Virginia Commonwealth University

Inclusion Criteria:
- Women 35-50 years of age, inclusive
- Patients who have declined or elected to defer RRSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm).
- At least one intact ovary and fallopian tube.
- Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required.
- Premenopausal; defined as <12 months of amenorrhea.

Exclusion Criteria:
- Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any prior time
- Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma.

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Prevention
  • Research Study Team Melanie Hamilton, RN
    Phone: +1 804-628-7130
    Email Study Contact

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