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.