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OBJECTIVE: To test whether annual screening with transvaginal ultrasonography and CA 125 reduces ovarian cancer mortality.

METHODS: Data from the first four annual screens, denoted T0–T3, are reported. A CA 125 value at or above 35 units/mL or an abnormality on transvaginal ultrasonography was considered a positive screen. Diagnostic follow-up of positive screens was performed at the discretion of participants’ physicians. Diagnostic procedures and cancers were tracked and verified through medical records.

RESULTS: Among 34,261 screening arm women without prior oophorectomy, compliance with screening ranged from 83.1%(T0) to 77.6%(T3). Screen positivity rates declined slightly with transvaginal ultrasonography, from 4.6 at T0 to 2.9–3.4 at T1–T3; CA 125 positivity rates (range 1.4–1.8%) showed no time trend. Eighty-nine invasive ovarian or peritoneal cancers were diagnosed; 60 were …