A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Bilateral Salpingectomy: Undergo bilateral salpingectomy
Bilateral Salpingectomy with Oophorectomy: Undergo bilateral salpingo-oophorectomy
Biospecimen Collection: Undergo blood sample collection
Magnetic Resonance Imaging: Undergo pelvic MRI
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transvaginal Ultrasound: Undergo transvaginal ultrasound
Ultrasound Imaging: Undergo pelvic ultrasound
Study summary
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
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.
More NRG Oncology trials in South Korea
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.
View NCT04251052 on ClinicalTrials.gov ↗ ← All trials in South Korea