General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04251052

Background Information

We are doing this study because we want to determine if two surgical procedures are no different for ovarian cancer risk reduction in individuals 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.

For more information, please visit: https://clinicaltrials.gov/study/NCT04251052

Offered At

Inova Schar Cancer Institute 
A division of Inova Fairfax Hospital 
8081 Innovation Park Drive 
Fairfax, VA 22031
Principal Investigator

Rebecca Kaltman, MD

Eligibility Information

  • Individuals 35-50 years of age, inclusive.
  • Patients who are undergoing 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 and consent.
  • 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 pathogenic or likely pathogenic germline BRCA1 mutation in the patient. 
  • Patients may be premenopausal or menopausal.
  • Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration.

Ineligibility Information

  • Individuals with a history of any prior cancer who have received chemotherapy within the past 30 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.