What is the Purpose of this Study?
This study aims to determine whether 2 surgical procedures are no different for ovarian cancer risk reduction in individuals with BRCA1 mutations who have completed childbearing. (Mutations in the BRCA1 gene are associated with a higher risk of breast cancer.) Researchers will compare the removal of fallopian tubes to the removal of fallopian tubes and ovaries. The study will also examine the factors that go into deciding which surgery to have, as well as evaluate the symptoms after surgery (symptoms caused by lack of estrogen due to ovary removal). The usual treatment approach is surgery to remove the fallopian tubes and ovaries at the same time. Participants will decide whether to undergo surgical removal of fallopian tubes (bilateral salpingectomy) or removal of fallopian tubes and ovaries (bilateral salpingo-oophorectomy).
Eligibility
- * Individuals 35-50 years of age, inclusive
- * Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
- * At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present
- * Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
Where can I participate?
- Cedars-Sinai Cancer at SOCC : Garrett Crook
- Huntington Hospital (CSMC Affiliate)
More about this Clinical Trial
What is the full name of this clinical trial?
A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferirority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]