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Baard J, Celebi M, de la Rosette J, Alcaraz A, Shariat S, Cormio L, Cavadas V, Laguna MP
Evaluation of Patterns of Presentation, Practice, and Outcomes of Upper Tract Urothelial Cancer: Protocol for an Observational, International, Multicenter, Cohort Study by the Clinical Research Office of the Endourology Society
Protocol for an International Prospective Registry to Evaluate Patterns of Presentation, Practice and Outcomes in Upper Tract Urothelial Cancer: the CROES-UTUC Registry
Joyce Baard;
Merve Celebi;
Jean de la Rosette;
Antonio Alcaraz;
Shahrokh Shariat;
Luigi Cormio;
Vitor Cavadas;
M. Pilar Laguna
ABSTRACT
Background:
Available guidelines on the management of urothelial carcinoma of the upper tract (UTUC) are restricted due to the lack of strong evidence based recommendations. Adequate well powered randomised trials are missing due to the rarity of the disease. To overcome this problem we need alternative study designs providing generalizable data.
Objectives:
The primary aim of this registry is to provide a real-world overview on patterns of presentation and management of UTUC. Secondary objectives include comparison of outcomes of different treatments and tumour stages and evaluation of compliance with the current EAU guidelines recommendations on UTUC.
Methods:
Patient characteristics: For this observational, international multicenter cohort study, clinical data of consecutive patients with suspicion of UTUC, irrespective of type of management, are prospectively collected up to five-years after inclusion.
Data collection and analysis: Data on patterns of presentation, diagnostic and treatment as well as short-, mid- and long-term oncological and functional outcomes will be analysed. Possible associations between variables, basal characteristics and outcomes will be tested by multivariable analyses. The methodology will address potential sources of bias and confounders.
Results:
The registry was initiated in November 2014 after IRB revision, data collection started in December 2014. As of submission of this manuscript 2451 patients from 125 centers from 37 countries have been included. Inclusion of patients is planned to close 5 years after initiation of the registry. The study is registered at ClinicalTrials.gov. Quality checks are done centrally with continuous communication and feedback with the centers to ensure accuracy. First results are expected in the first trimester of 2020.
Conclusion:
This large observational prospective cohort will generate landmark “real-world” data and hypothesis for further studies. We expect these data will optimize management of UTUC, provide insights in harms and benefits and serve as quality control.
Citation
Please cite as:
Baard J, Celebi M, de la Rosette J, Alcaraz A, Shariat S, Cormio L, Cavadas V, Laguna MP
Evaluation of Patterns of Presentation, Practice, and Outcomes of Upper Tract Urothelial Cancer: Protocol for an Observational, International, Multicenter, Cohort Study by the Clinical Research Office of the Endourology Society