JMIR Publications

ABSTRACT

Introduction: Urothelial carcinoma of the upper tract (UTUC) has a low prevalence. Guidelines on diagnostics and management are based on low evidence studies. The primary aim of this registry is to provide a real-world overview on incidence and management of UTUC. Secondary objectives include compliance of practice with the current guidelines. Methods and analysis: The design of this international registry is compliant with the recommendations of the Agency for Health Care Research and Quality and are under the auspices of the Clinical Research Office of the Endourology Society (CROES). Clinical data of consecutive patients with suspicion of any UTUC is anonymized and prospectively collected up to five-years after inclusion, irrespective of treatment or management. The CROES statisticians will perform data audit, cleaning and statistical analysis. Statistical analysis will be tailored to the specific objectives after study approval by the Steering Committee. Descriptive statistics will be used to summarize data. A significance level of 5% will be maintained and all tests will be two-sided. All analyses will be carried out on available data, with reporting of missing data proportions. Possible associations between variables and basal characteristics and outcomes will be tested by multivariable analyses. The methodology will address potential sources of bias and confounders. If necessary, sensitivity analysis will be conducted. We will not use external data sources for comparison unless considered of outmost importance for specific objectives. Ethics and dissemination IRB approval was requested and judged not necessary according to the Medical Research Involving Human Subjects Act. As large observational prospective cohort, the registry will generate landmark “real-world” data and hypothesis for further studies. Congress presentations and several publications are foreseen on primary and secondary objectives as well as future “ad hoc” studies. We expect these data will optimize management of UTUC, provide insights in harms and benefits and serve as quality control. Trial registration: version 2, September 2014. NCT02281188 in ClinicalTrials.gov