CLINICAL TRIAL / NCT04251052
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
- Observational
- Recruiting
- NCT04251052
Contact Information
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]
This study 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.
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: This is an observational study. Patients choose between 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 pelvic or 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.
Gender
Female
Age Group
35 Years to 50 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
- 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
- Patients may be premenopausal or menopausal
- Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is
acceptable) 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 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, CA-125) suspicious for
occult or gross pelvic malignancy within the past 180 days
- An abnormal pelvic ultrasound is defined as morphologic or structural
variations suspicious for ovarian malignancy. Complex cystic lesions felt to
represent a benign lesion are not exclusionary. Simple cysts of any size are
not exclusionary
- 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 individuals who are current users
of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level
> 35 U/ml in postmenopausal individuals