The European NAFLD Registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease

on behalf of the LITMUS Consortium, Timothy Hardy, Kristy Wonders, Ramy Younes, Guruprasad P. Aithal, Rocio Aller, Michael Allison, Pierre Bedossa, Fay Betsou, Jerome Boursier, M. Julia Brosnan, Alastair Burt, Jeremy Cobbold, Helena Cortez-Pinto, Chris P. Day, Jean Francois Dufour, Mattias Ekstedt, Sven Francque, Stephen Harrison, Luca MielePatrik Nasr, George Papatheodoridis, Salvatore Petta, Dina Tiniakos, Richard Torstenson, Luca Valenti, Adriaan G. Holleboom, Hannele Yki-Jarvinen, Andreas Geier, Manuel Romero-Gomez, Vlad Ratziu, Elisabetta Bugianesi, Jörn M. Schattenberg, Quentin M. Anstee

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Article number106175
JournalContemporary Clinical Trials
Volume98
DOIs
Publication statusPublished - Nov 2020

Keywords

  • Biomarker
  • Cirrhosis
  • NAFLD
  • NASH

ASJC Scopus subject areas

  • Pharmacology (medical)

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