Ovarian Cancer Screening Pilot Trial In High Risk Women
No coordinating investigator defined.
BACKGROUND: No proven ovarian cancer (OC) screening strategy exists for women who are at increased risk for the disease. A risk of ovarian cancer algorithm (ROCA) using serial CA125 values have previously shown greater positive predictive value (PPV) and sensitivity than a single CA125 in screening women at general population risk. We hypothesized that using ROCA would yield a reasonable PPV for ovarian cancer screening in a cohort at increased risk. METHODS: Between 7/2001 and 9/2006, 25 sites (14 CGN, 3 ovarian SPOREs, 1 EDRN, 7 others) prospectively enrolled patients. Inclusion criteria included: among self, 1st degree and 2nd degree relatives in same lineage either (i) BRCA 1/2 mutation, or (ii) two of OC or early onset (age < or = 50) breast cancer (BC), or (iii) Ashkenazi ethnicity and 1 of OC or BC. A previous diagnosis of OC excluded subjects. Subjects underwent CA125 every 3 months and the risk of having ovarian cancer based on the CA125 profile was recalculated after each test. ROCA referred subjects with risk > 1% to ultrasound (US) and risk > 10% additionally to a gynecologic oncologist. Objectives included PPV for study indicated surgery, sensitivity, and compliance. Sample size was chosen to observe 8 OC endpoints with a power of 80% to rule out PPV < or = 10% if the true PPV = 20%.
There are currently no biomarkers annotated for this protocol.
No datasets are currently associated with this protocol.