A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Launched by NRG ONCOLOGY · Jan 30, 2020
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different surgical procedures to see which one better reduces the risk of ovarian cancer in women with BRCA1 mutations. The two procedures being compared are bilateral salpingectomy, where only the fallopian tubes are removed, and bilateral salpingo-oophorectomy, where both the fallopian tubes and ovaries are removed. The goal is to help doctors understand if one procedure is more effective than the other in preventing ovarian cancer for these patients.
To participate in this trial, women aged 35 to 50 who have tested positive for a BRCA1 mutation may be eligible. They can either choose to undergo the surgery right away or decide to delay it while still being monitored. Participants must have at least one ovary and one fallopian tube intact at the time of enrollment. Before joining, they will need to give informed consent and complete certain health tests to ensure they are suitable for the procedures. If they join the study, participants can expect to receive ongoing medical care and monitoring as part of the trial. This research is important because it aims to provide clearer guidelines for women at risk of ovarian cancer due to their genetic background.
Gender
FEMALE
Eligibility criteria
- 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
About Nrg Oncology
NRG Oncology is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative multi-institutional studies. Comprising a collaborative network of leading academic institutions and community hospitals, NRG Oncology focuses on enhancing patient outcomes by conducting rigorous clinical trials that evaluate new treatment strategies and improve existing therapies. With a commitment to scientific excellence and patient-centered care, the organization plays a vital role in shaping the future of oncology by integrating cutting-edge research with clinical practice, ultimately striving to translate findings into meaningful improvements in cancer care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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New Hyde Park, New York, United States
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Mineola, New York, United States
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Normal, Illinois, United States
Seattle, Washington, United States
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Grand Rapids, Michigan, United States
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Patients applied
Trial Officials
Kathryn P Pennington
Principal Investigator
NRG Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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