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, click the link below:
https://clinicaltrials.gov/study/NCT04251052?term=CC008&rank=2
Key Participation Requirements
Trial Location(s)
Gender
Female
Age
35 to 50 years old
Enrollment Status
Recruiting
Phase
Not Applicable
Methodist Health System Trial Code
CC008