A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]
Description
Brief 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.
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.