IRB Study Number 20-1163
Status Recruiting
Locations Cleveland Clinic Main Campus, Fairview Hospital, Hillcrest Hospital
Institute Taussig Cancer Institute
Description
1.1 Primary Objective
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.(26-MAY-2022)
1.2 Secondary Objectives (26-MAY-2022)
1.2.1 To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the FACT-ES subscale compared to pre-menopausal patients in the BSO arm.
1.2.2 To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL) and sexual dysfunction (FSFI)in pre-menopausal patients who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from pre-menopausal BSO patients.
1.2.3 To determine if health-related QOL (FACT) is negatively impacted by cancer distress (IES) in individuals who have undergone BLS, in comparison to BSO patients.
1.2.4 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.
1.2.5 To assess adverse events, graded using CTCAE v5.0.
Inclusion Criteria
3.1.1 Individuals 35-50 years of age, inclusive.
3.1.2 Patients who are undergoing 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.
3.1.3 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. (04-MAY-2021) Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present. (09-SEP-2021)
3.1.4 Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required.
3.1.5 Patients may be premenopausal or menopausal.
3.1.6 Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration.
3.1.7 The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
3.1.8 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
3.2.1 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.
3.2.2 Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma.
3.2.3 Patients medically unfit for the planned surgical procedure.
3.2.4 Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days.
a) An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts <5cm in maximal diameter are not exclusionary).
b) An abnormal CA-125 is defined as a level >50U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level >40U/ml for premenopausal individualss who are current users of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level >35 U/ml in postmenopausal individuals.
