Screening for ovarian cancer: a pilot randomised controlled trial

Background The value of screening for ovarian cancer is uncertain. We did a pilot randomised trial to assess multimodal screening with sequential CA 1 25 antigen and ultrasonography. Methods Postmenopausal women aged 45 years or older were randomised to a co ntrol group (n=10 977) or screened group (n=10 958). Women randomised to sc reening were offered three annual screens that involved measurement of seru m CA 125, pelvic ultrasonography if CA 125 was 30 U/mL or more, and referra l for gynaecological opinion if ovarian volume was 8.8 mt or more on ultras onography. All women were followed up to see whether they developed invasiv e epithelial cancers of the ovary or fallopian tube tinder cancers). Findings Of 468 women in the screened group with a raised CA 125, 29 were r eferred for a gynaecological opinion; screening detected an index cancer in six and 23 had false positive screening results. The positive predictive v alue was 20.7%. During 7-year follow-up, ten further women with index cance rs were identified in the screened group and 20 in the control group. Media n survival of women with index cancers in the screened group was 72.9 month s and in the control group was 41.8 months (p=0.0112), The number of death' s from an index cancer did not differ significantly between the control and screened groups (18 of 10 977 vs nine of 10 958, relative risk 2.0 [95% CI 0.78-5.13]). Interpretation These results show that a multimodal approach to ovarian can cer screening in a randomised trial is feasible acid justify a larger rando mised trial to see whether screening affects mortality,