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.
Eligibility
Sex
FEMALE
Min age
35 Years
Max age
50 Years
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) 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 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, 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
Primary outcome measure(s)
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers — Up 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.
Trial sites (574)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Recruiting
Anchorage Associates in Radiation Medicine
Anchorage
Alaska
Recruiting
Anchorage Radiation Therapy Center
Anchorage
Alaska
Suspended
Alaska Breast Care and Surgery LLC
Anchorage
Alaska
Recruiting
Alaska Oncology and Hematology LLC
Anchorage
Alaska
Recruiting
Alaska Women's Cancer Care
Anchorage
Alaska
Recruiting
Katmai Oncology Group
Anchorage
Alaska
Recruiting
Providence Alaska Medical Center
Anchorage
Alaska
Recruiting
CTCA at Western Regional Medical Center
Goodyear
Arizona
Active Not Recruiting
Banner University Medical Center - Tucson
Tucson
Arizona
Recruiting
University of Arizona Cancer Center-North Campus
Tucson
Arizona
Recruiting
University of Arkansas for Medical Sciences
Little Rock
Arkansas
Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch
California
Recruiting
Tower Cancer Research Foundation
Beverly Hills
California
Recruiting
Keck Medicine of USC Buena Park
Buena Park
California
Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
California
Recruiting
Mercy Cancer Center - Carmichael
Carmichael
California
Recruiting
Mercy San Juan Medical Center
Carmichael
California
Recruiting
City of Hope Comprehensive Cancer Center
Duarte
California
Recruiting
Kaiser Permanente Dublin
Dublin
California
Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove
California
Recruiting
Kaiser Permanente-Fremont
Fremont
California
Recruiting
Fresno Cancer Center
Fresno
California
Suspended
Kaiser Permanente Fresno Orchard Plaza
Fresno
California
Recruiting
Kaiser Permanente-Fresno
Fresno
California
Recruiting
City of Hope Seacliff
Huntington Beach
California
Recruiting
Keck Medicine of USC Huntington Beach
Huntington Beach
California
Recruiting
City of Hope at Irvine Lennar
Irvine
California
Recruiting
Kaiser Permanente-Irvine
Irvine
California
Recruiting
City of Hope Antelope Valley
Lancaster
California
Recruiting
Keck Medicine of USC Koreatown
Los Angeles
California
Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles
California
Recruiting
Los Angeles General Medical Center
Los Angeles
California
Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles
California
Recruiting
Cedars-Sinai Medical Center
Los Angeles
California
Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles
California
Recruiting
Kaiser Permanente- Modesto MOB II
Modesto
California
Recruiting
Kaiser Permanente-Modesto
Modesto
California
Recruiting
Providence Queen of The Valley
Napa
California
Recruiting
USC Norris Oncology/Hematology-Newport Beach
Newport Beach
California
Recruiting
+ 534 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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