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NRG CC008

Trial Overview

Official Title

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]

Study Purpose

The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.

Diagnosis

Patients who have a BRCA1 mutation and they have elected to undergo a surgical intervention.

Eligibility

Women 35-50 years old with BRCA1 mutation with at least one intact ovary and fallopian tube.

Must be pre-menopausal.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

This study has two study groups:

  • BLS Group (Bilateral Salpingectomy): Patients who are in the BLS group have chosen to only have your fallopian tubes removed at this time with the plan to remove your ovaries during a second operation when you are closer to menopause.
  • BSO Group (Bilateral Salpingo-Oophorectomy): Patients who are in the BSO group have chosen to have your fallopian tubes and ovaries removed together at the same time.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Female
Age
35 to 50 years old
Enrollment Status
Recruiting
Phase
Not Applicable
Methodist Health System Trial Code
CC008