Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This clinical trial studies how well two surgical procedures (bilateral salpingectomy and
bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals
with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian
tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the
fallopian tubes and ovaries. This study may help doctors determine if the two surgical
procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1
mutations.
Phase
N/A
Funding Agency/Sponsor
National Cooperative Group
Disease
Gynecologic Cancer
Enrollment Eligibility
Inclusion Criteria:
- Individuals 35-50 years of age, inclusive
- Patients who are undergoing 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 and
consent. Prior hysterectomy is allowed provided it did not include bilateral
salpingectomy. Prior tubal ligation is allowed if one intact 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
- Patients may be premenopausal or menopausal
- Transvaginal ultrasound (TVUS) 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
Exclusion Criteria:
- 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
- An abnormal TVUS is defined as morphologic or structural variations suspicious
for ovarian malignancy or complex cystic lesions (simple cysts < 5 cm in maximal
diameter are not exclusionary)
- An abnormal CA-125 is defined as a level > 50 U/ml in premenopausal individuals
if they are not current users of oral contraceptives; an abnormal CA-125 is
defined as a level > 40 U/ml for premenopausal individuals who are current users
of oral contraceptives. An abnormal CA-125 is defined as a level > 35 U/ml in
postmenopausal individuals.