Prospective Trial for Examining Hematuria using Computed Tomography (PROTEHCT) is a prospective clinical trial at Oslo University Hospital, Aker. Division of Radiology and Nuclear medicine. The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urinary tract cancer in patients with hematuria compared to the traditional four-phase CT (control).
Two different radiologists will independently examine and report the experimental and control arm, and in addition, there will be a secondary investigation for extra control. Each series is classified according to a 5-point Likert score, and then dichotomized as negative (1 or 2) or positive (3-4-5) with respect to detecting urinary tract cancer.
DIPS Arena is the EHR system used by the radiologists. The application is developed using openEHR archetypes for the different scores used in the study. All patients to be included in this study is included in “Pakkeforløp kreft”. These patients are followed up using a patient list where trajectory specific events are recorded. The application developed for the study use a modified patient list based on this population to do the study specific entries. Using the EHR as a platform for clinical trials has several benefits. Since every entry is versioned and stored in the EHR the research program all data has complete traceability and version logs. The end user will follow up the patients as normal, i.e. there will be no extra software to start up. Access control to data is handled by the ordinary national regulations.
The study starts this autumn (2019) and is estimated to last 1,5 years until the sample size is large enough.