Working Group 4

EPIDEMIOLOGY, CLINICAL CHARACTERIZATION AND TRIALS

The aim of WG4 will be the creation of a data registry using the online REDCap™ (Research Electronic Data Capture) platform (http://project-redcap.org/). From this registry, new and key data will be derived that can be used to generate specific guidelines for patients and physicians for the standard care of CCA. Considering the lack of consistency and heterogeneity among CCA studies, it is imperative to set standards for clinical trials design and establish precise endpoints to assess the efficacy of novel interventions or for exploring novel biomarkers in CCA.

Tasks & Activities

The primary goal of the clinical-epidemiology data registry will be to establish a follow-up of the natural history of CCA in European countries:

• To determine the current management of patients and outcomes.
• To broaden the current CCA classification by introducing information about morphological, immunohistochemical, genetic and molecular parameters.
• To elucidate the role of environmental factors in the development and progression of CCA.
• To compare the effectiveness of different therapies (e.g., standardised surgical approaches).
• To select patients for clinical trials. To explore the access to clinical trial for patients, the patients’ outcomes and treatment strategies and consistency across countries.
• To propose guidelines on CCA management.
• To attract support for planning, setting-up and coordinating observational and interventional multicentre clinical trials in CCA.