Gynecological Cancer
NRG-CC008: 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]
Description
This is a non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRAC1 carriers.
Inclusion Notes
For a full description of this trial, please go to the listing on www.clinicaltrials.gov
Eligibility Criteria
A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
- Individuals 35-50 years of age, inclusive.
- Patients who will undergo 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 CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required.
- Patients may be premenopausal or menopausal.
- Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) and CA-125 within 180 days of registration.
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
- Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future.
Start Date
Tuesday, September 1, 2020
Principal / Contact Name
Sarah E. Gill, MD