What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Bilateral Salpingectomy, Bilateral Salpingectomy with Oophorectomy, or Biospecimen Collection. The registry lists allocation as randomized. 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.
They plan to enroll about 1,956 people at 630 sites. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]
Interventions: Bilateral Salpingectomy, Bilateral Salpingectomy with Oophorectomy, Biospecimen Collection, Magnetic Resonance Imaging, Quality-of-Life Assessment, Questionnaire Administration, Transvaginal Ultrasound, Ultrasound Imaging
Primary outcome (registry wording): Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers