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

Recruiting now · Not applicable

Conditions studied: Ovarian Carcinoma

In brief

This clinical trial 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.

Key facts

Study ID: NCT04251052
Run by: NRG Oncology
People needed: 1956
Starts: 2020-09-01
Expected to finish: 2047-06-30
Last updated by the study team: 2026-08-07

Who can join

Age: 35 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Keck Medicine of USC Huntington Beach — Huntington Beach, California, United States (enrolling)
University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (enrolling)
Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States (enrolling)
City of Hope Seacliff — Huntington Beach, California, United States (enrolling)
Alaska Women's Cancer Care — Anchorage, Alaska, United States (enrolling)
Katmai Oncology Group — Anchorage, Alaska, United States (enrolling)
Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States (enrolling)
Banner University Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States (enrolling)
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States (enrolling)
Tower Cancer Research Foundation — Beverly Hills, California, United States (enrolling)
Keck Medicine of USC Buena Park — Buena Park, California, United States (enrolling)
Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States (enrolling)
Mercy Cancer Center - Carmichael — Carmichael, California, United States (enrolling)
Mercy San Juan Medical Center — Carmichael, California, United States (enrolling)
City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
Kaiser Permanente Dublin — Dublin, California, United States (enrolling)
Mercy Cancer Center - Elk Grove — Elk Grove, California, United States (enrolling)
Kaiser Permanente-Fremont — Fremont, California, United States (enrolling)
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States (enrolling)
Kaiser Permanente Fresno Orchard Plaza — Fresno, California, United States (enrolling)
Kaiser Permanente-Fresno — Fresno, California, United States (enrolling)
City of Hope at Irvine Lennar — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

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