Title
A Non-randomized Prospective Clinical Trial Comparing the Noninferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCK]

Description
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

Objective
The main purpose of this study is to determine if two surgical procedures, the usual approach of removing the fallopian tubes and ovaries and the other approach of removing the fallopian tubes at this time with the plan to remove the ovaries at a later time, are no different for ovarian cancer risk reduction in women with BRCA1 mutations who have completed childbearing. In this study, the removal of fallopian tubes will be compared to the removal of fallopian tubes and ovaries. The study will also examine what factors go into deciding which surgery to have and symptoms after surgery caused by lack of estrogen due to ovary removal

Treatment
This study has 2 study groups:

BLS Group (Bilateral Salpingectomy): If you are in the BLS group you 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. All surgical procedures and related decisions are completely within your control and will be supported by the study physician

BSO Group (Bilateral Salpingo-Oophorectomy): If you are in the BSO group you have chosen to have your fallopian tubes and ovaries
removed together at the same time

Key Eligibility
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 less than 12 months of amenorrhea. However, for those patients with greater than or equal to 12 months of amenorrhea who may be pre-menopausal or patients with a prior hysterectomy with at least one retained ovary/tube, levels of FSH, LH, and in the pre-menopausal range per local institutional standards will be acceptable

Concurrently planned or prior hysterectomy is permitted as long as at least one fallopian tube and one ovary had been retained

Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration

Patient must have negative urine pregnancy test within 14 days prior to registration based on local institutional policies

EXCLUSION

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

Patients medically unfit for the planned surgical procedure

Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days. An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts less than 5cm in maximal diameter are not exclusionary). An abnormal CA-125 is defined as a level greater than 50U/ml in this study population of premenopausal women if they are not current users or oral contraceptives; an abnormal CA-125 is defined as a level greater than 40U/ml for premenopausal women who are current users of oral contraceptives

Women who are currently pregnant or plan to become pregnant in the future

Applicable Disease Sites
Ovary

Participating Institutions
UW Health University Hospital