PRIMARY OBJECTIVE:
I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations.
SECONDARY OBJECTIVES:
I. To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES) subscale compared to pre-menopausal patients in the BSO arm.
II. To determine if health-related quality of life (QOL) (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-Menopausal Symptom Checklist \[MSCL\]) and sexual dysfunction (Female Sexual Function Index \[FSFI\]) in pre-menopausal patients who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from pre-menopausal BSO patients.
III. To determine if health-related QOL (FACT) is negatively impacted by cancer distress (Impact of Event Scale \[IES\]) in individuals who have undergone BLS, in comparison to BSO patients.
IV. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.
V. To assess adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
EXPLORATORY OBJECTIVES:
I. Sexual dysfunction, as measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items (pre-menopausal patients).
II. To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction.
III. To assess medical decision making, as measured by the Risk-Reducing Medical Decision Making (RR-MDM) survey, a targeted set of questions on risk reducing surgical treatment choice.
TRANSLATIONAL RESEARCH OBJECTIVE:
I. To bank tissue and blood biospecimens for future research.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery.
GROUP II: Patients undergo bilateral salpingo-oophorectomy.
Patients in both groups also undergo a transvaginal ultrasound during screening and blood sample collection throughout the trial.
After completion of study, patients are followed up at 10-60 days, 6, 12, and 24 months, and then annually for up to 20 years.
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.