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Comparing Two Surgeries for Ovarian Cancer Risk in BRCA1 Carriers

This study is comparing two surgical procedures, bilateral salpingectomy (removal of fallopian tubes) and bilateral salpingo-oophorectomy (removal of fallopian tubes and ovaries), to see how well they reduce the risk of ovarian cancer in women with BRCA1 gene mutations. You may be able to join if you are a woman between 35 and 50 years old with a BRCA1 mutation. The study aims to find out if bilateral salpingectomy with delayed oophorectomy is as effective as bilateral salpingo-oophorectomy in preventing high-grade serous carcinomas (a type of ovarian cancer). Researchers will also look at quality of life and menopausal symptoms. The current status of this study is unclear, and it plans to enroll 1956 participants.

Study design
This interventional study plans to enroll 1956 women. It compares two surgical procedures: bilateral salpingectomy and bilateral salpingo-oophorectomy.
What's involved
You would undergo one of the two surgical procedures and have blood samples collected. You would also have a pelvic MRI and complete quality-of-life assessments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 20 years to track the development of high-grade serous carcinomas.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04251052

A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

Recruiting
NAAges 35–50InterventionalPrevention
NRG Oncology
~1,956 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Bilateral SalpingectomyBilateral Salpingectomy with OophorectomyBiospecimen CollectionMagnetic Resonance ImagingQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
486 of 574 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers
Measured over Up to 20 years

Conditions

Ovarian Carcinoma

Explore related trials

Malignant Ovarian NeoplasmBRCA1 Gene

Where it's being run

574 sites across 53 states
California67
Illinois44
Ohio41
New York32
Florida30
Michigan30
Minnesota30
Wisconsin27

Study leadership

  • Kathryn P Pennington · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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) or pelvic MRI 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

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
An abnormal pelvic ultrasound (or pelvic MRI) 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

What this trial measures

  • Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancersUp to 20 years

    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.