The UKCTOCS is a randomised controlled trial aiming to assess the impact of screening on mortality from ovarian cancer while comprehensively evaluating performance characteristics of the screening strategies, physical and psychological morbidity, compliance, and cost. The design involves 200 000 women randomised to annual screening with serum CA 125 or transvaginal ultrasound or no intervention (fig 1). The inclusion criteria were women aged 50-74 and with postmenopausal status; the exclusion criteria were bilateral oophorectomy, previous ovarian malignancy, increased risk of familial ovarian cancer, active non-ovarian malignancy, and participation in other ovarian cancer screening trials.
A senior investigator leads trial management based at the coordinating centre. We use a custom built, web based trial management system to centralise and automate trial processes. We identified NHS trusts (trial centres) wishing to participate and set them up in a staggered fashion over the course of two years. Recruitment started at a trial centre when at least 1500 local women had accepted the invitation. The launch of the trial was accompanied by national media coverage. This was followed by local media coverage in the form of radio interviews and newspaper articles as each centre started recruitment. We briefed the staff manning the telephone lines of the patient support charities OVACOME and Cancer BACUP and provided them with answers to frequently asked questions before any publicity.
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