RT Journal Article T1 The European NAFLD Registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease. A1 Hardy, Timothy A1 Wonders, Kristy A1 Younes, Ramy A1 Aithal, Guruprasad P A1 Aller, Rocio A1 Allison, Michael A1 Bedossa, Pierre A1 Betsou, Fay A1 Boursier, Jerome A1 Brosnan, M Julia A1 Burt, Alastair A1 Cobbold, Jeremy A1 Cortez-Pinto, Helena A1 Day, Chris P A1 Dufour, Jean-Francois A1 Ekstedt, Mattias A1 Francque, Sven A1 Harrison, Stephen A1 Miele, Luca A1 Nasr, Patrik A1 Papatheodoridis, George A1 Petta, Salvatore A1 Tiniakos, Dina A1 Torstenson, Richard A1 Valenti, Luca A1 Holleboom, Adriaan G A1 Yki-Jarvinen, Hannele A1 Geier, Andreas A1 Romero-Gomez, Manuel A1 Ratziu, Vlad A1 Bugianesi, Elisabetta A1 Schattenberg, Jörn M A1 Anstee, Quentin M A1 LITMUS Consortium, K1 Biomarker K1 Cirrhosis K1 NAFLD K1 NASH AB Non-Alcoholic Fatty Liver Disease (NAFLD), a progressive liver disease that is closely associated with obesity, type 2 diabetes, hypertension and dyslipidaemia, represents an increasing global public health challenge. There is significant variability in the disease course: the majority exhibit only fat accumulation in the liver but a significant minority develop a necroinflammatory form of the disease (non-alcoholic steatohepatitis, NASH) that may progress to cirrhosis and hepatocellular carcinoma. At present our understanding of pathogenesis, disease natural history and long-term outcomes remain incomplete. There is a need for large, well characterised patient cohorts that may be used to address these knowledge gaps and to support the development of better biomarkers and novel therapies. The European NAFLD Registry is an international, prospectively recruited observational cohort study that aims to establish a large, highly-phenotyped patient cohort and linked bioresource. Here we describe the infrastructure, data management and monitoring plans, and the standard operating procedures implemented to ensure the timely and systematic collection of high-quality data and samples. Already recruiting subjects at secondary/tertiary care centres across Europe, the Registry is supporting the European Union IMI2-funded LITMUS 'Liver Investigation: Testing Marker Utility in Steatohepatitis' consortium, which is a major international effort to robustly validate biomarkers that diagnose, risk stratify and/or monitor NAFLD progression and liver fibrosis stage. The European NAFLD Registry has the demonstrable capacity to support research and biomarker development at scale and pace. YR 2020 FD 2020-10-09 LK http://hdl.handle.net/10668/16403 UL http://hdl.handle.net/10668/16403 LA en DS RISalud RD Apr 4, 2025