This clinical trial evaluates 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.
Individuals 35-50 years of age, inclusive
Patients who will undergo 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, consent, and registration. 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 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
Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed.
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 (pelvic ultrasound, pelvic MRI, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days
Parallel
Bilateral Salpingectomy
Procedure/SurgeryUndergo bilateral salpingectomy
Bilateral Salpingectomy with Oophorectomy
Procedure/SurgeryUndergo bilateral salpingo-oophorectomy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Magnetic Resonance Imaging
Procedure/SurgeryUndergo pelvic MRI
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Transvaginal Ultrasound
Procedure/SurgeryUndergo transvaginal ultrasound
Ultrasound Imaging
Procedure/SurgeryUndergo pelvic ultrasound
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers
Will be assessed using a stratified log rank test, stratifying for age. The effects of other covariates, such as familial history of gynecologic cancer, time to crossover for bilateral salpingectomy (BLS) patients, and age at study entry, will be adjusted for in Cox proportional hazard models. Patients who crossover will be analyzed according to the initial surgery received at study enrollment as this will reflect actual practice.
Health-related quality of life (QOL)
Will be measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES). The FACT total score (calculated from the physical, functional, social and emotional well-being subscales) and ES subscale will be assessed. Scores range from 0 to 76. Higher scores indicate better QOL for the FACT-ES and better functioning for the Female Sexual Function Index (FSFI) total score.
Cancer distress
Will be measured by the Impact of Events Scale (IES). The total score can range from 0 to 88, with higher scores indicating a greater impact of the event.
Medical decision making
Will be measured by the Shared Decision Making Questionnaire (SDM-Q-9) and, Decisional Regret Scale. The SDM-Q-9 total score and Decisional Regret Scale total score at each time point of collection will be compared between arms using a t-test with a significance level of 0.05. A linear model will be used to assess the association of the SDM-Q-9 total score with treatment arm and patient characteristics such as age and race. A similar model will be used to assess the association of the Decisional Regret Scale total score with treatment arm and patient characteristics such as age, race, crossover from BLS arm, and hysterectomy status. Minimum score of 0 and a maximum score of 45. A higher score indicates a greater level of perceived shared decision-making in a consultation.
Incidence of adverse events
Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Counts and frequencies will be provided for the worst grade adverse event (AE) experienced by the patient by treatment arm. The distribution of AE grade in the BLS arm will be compared to the bilateral salpingo-oophorectomy arm using a chi-square test, or Fisher's exact test if cell frequencies are \< 5, at the one-sided 0.05 significance level.
Cost effectiveness
Will be measured by European Quality of Life Five Dimension Five Level Scale Questionnaire. A Markov model will be used to model cost. Scores range from 0 to 100 with higher score indicating better overall health.
Sexual dysfunction (pre-menopausal patients only)
Will be measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items. Each item will be analyzed separately and compared between treatment arms using a chi-square test. Scores range from 0 to 100 with higher score indicating more of the concept being measured.
Health related (HR)-QOL
Will examine the correlation between HR-QOL, as measured by the FACT, with menopausal symptoms, as measured by the MSCL, sexual dysfunction, as measured by FSFI, and PROMIS screener and external sexual function items and cancer distress as measured by the IES. Pearson correlation coefficients will be used for correlating the FACT total score with the FSFI overall score and Impact of Events Scale total distress score. Spearman correlation coefficients will be used to assess the correlation between FACT total score and the Menopausal Symptom Checklist symptoms, FSFI, and PROMIS items.
Risk-reducing medical decision making validation and assessment
Measured by population-specific items examining the factors associated with the risk reducing surgical treatment choice. Will by assessed using the Risk-Reducing Medical Decision Making survey.
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NRG Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator
