Objective: To determine the feasibility of a randomised trial of ovarian cancer screening among women attending a breast cancer screening centre.
Design: Randomised controlled trial of ovarian cancer screening using transvaginal ultrasonography as a primary screening test and colour Doppler imaging as a secondary screening test in the screened group and no intervention in the control group.
Setting: Reading breast cancer screening centre (United Kingdom).
Subjects: 8678 women, without a bilateral oophorectomy or hysterectomy, aged between 50 and 64 attending for NHS breast cancer screening between September 1989 and February 1993.
Main outcome measures: Uptake of ovarian cancer screening among eligible women and the screening false positive rate (considered as the referral rate to a gynaecologist for surgical intervention).
Results: 82% (7124/8678) of eligible women agreed to join the trial and were randomly allocated in equal numbers to each arm of the trial. 3280 women had an initial scan. The false positive rate after ultrasonography alone was 2.9% (86/2952), but this dropped to 0.5% after colour Doppler as a secondary screening test. One stage I primary ovarian cancer was detected at screening in a 58 year old women.
Conclusions: A randomised trial of ovarian cancer screening using ultrasonography and colour Doppler imaging is feasible and acceptable among women attending a breast cancer screening centre. The results indicate that the expected odds of being affected given a positive result in the general population would be about 1:12. A full randomised trial of ovarian cancer screening with mortality as the end point is needed to assess whether screening reduces mortality from this disease. A multicentre European trial is currently in progress.