United Kingdom Collaborative Trial of Ovarian Cancer (UKCTOCS)

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Ovarian cancer (OC) is responsible for over 4000 deaths in the UK each year. The overall 5 year survival rate is only 35% but women diagnosed with early stage disease have survival rates as high as 90%. During the last decade the applicants have conducted large prospective screening trials which have identified two screening strategies with encouraging sensitivity and specificity for preclinical detection of OC. The proposal is for a three armed randomised controlled trial to assess the impact of these screening strategies in the general population. A total of 200,000 postmenopausal women, aged 50-74 years will be randomised in a 1:1:2 ratio to ultrasound screening, multimodal screening or a control group who will not be screened. Screening will occur in 12 collaborating gynaecological oncology centres in the UK and participants randomised to screening will undergo 6 screens at annual intervals. Ultrasound screening will involve a level I screen with transvaginal ultrasonography (TVS) to document abnormalities of ovarian morphology and volume. Multimodal screening will involve a level I screen with CA 125 to calculate the Risk of OC. Women with abnormal level I screening results in either group will be recalled for a level II screen with TVS and the small proportion of women with abnormal level II results will be referred for specialist surgical assessment. All participants will be followed up by postal questionnaire and via the cancer registry. The primary end point of the study will be OC mortality at 7 years after randomisation. Additional end points will include quality of life, health economics, morbidity and compliance with screening. The trial has 90% power to detect a 30% reduction in OC mortality in the screened groups compared to the control group. The results of the trial will form the basis for an informed decision about the place of general population screening for OC.