The European Randomised Trial of Ovarian Cancer Screening (ERTOCS) was awarded a research contract with the European Commission as a concerted action project under the Biomedical and Health Research Programme (Biomed 1) in 1993 (Contract No. BMHI-CT93-1741). The project is a multicentre randomised trial of ovarian cancer screening using ultrasound examination of the ovaries. This project seems to provide a network resource under Reinforced Concertation for an integrated ultrasound screening management system that will combine two basic elements, (I) the capture and storage of digitised ultrasound images from the trial using new high-density CD-ROM storage technology and, (ii) interactive software linking the digitised ultrasound images with administrative and clinical data, follow-up details of cancer and death, and freezer locations of samples stored in the biological specimen bank (serum for tumour markers and whole blood for DNA studies). This will be a valuable technical aid in providing the specialised quality control needed for the management of the trial. This network resource will contain all the data (ultrasound images, clinical data and biological samples) in one electronic system. Although serum banking for epidemiological studies is not new, storage of ultrasound images has not been done in this way before and will provide a unique system for quality control in imagine and monitoring ultrasound screening programmes. For example, a screening test can be judged to be positive on the volume of the ovary as measured by the ultrasonographer. Readings that are consistently too high will result in too high a false positive rate. Images cannot normally be retrieved so whether or not the reading accounts for the false positive rate cannot be determined retrospectively. With this system the images can be retrieved and evaluated providing quality assurance in imaging techniques ultrasound screening programmes can be objectively monitored. In addition, if a case of ovarian cancer were missed by screening, it would be possible to identify and locate the relevant stored serum samples and ultrasound images and retrieve them to see if the cancer might have been detected much like a pathologist might retrieve a slide for review after a missed diagnosis.
The proposed system permits examination of all trial data at the co-ordinating centre on a monthly basis so that if problems emerge there can be rapid feedback to local centres. This system offers, in one package, trial management and quality assurance that previously could not be achieved. It will also provide a bank of images, normal and abnormal, that can be used as a teaching package for ultrasonographers involved in ovarian cancer screening.