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

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LITMUS Consortium , Hardy , T , Wonders , K , Younes , R , Aithal , G P & Yki-Järvinen , H 2020 , ' The European NAFLD Registry : A real-world longitudinal cohort study of nonalcoholic fatty liver disease ' , Contemporary Clinical Trials , vol. 98 , 106175 . https://doi.org/10.1016/j.cct.2020.106175

Title: The European NAFLD Registry : A real-world longitudinal cohort study of nonalcoholic fatty liver disease
Author: LITMUS Consortium; Hardy, Timothy; Wonders, Kristy; Younes, Ramy; Aithal, Guruprasad P.; Yki-Järvinen, Hannele
Contributor: University of Helsinki, Department of Medicine
Date: 2020-11
Language: eng
Number of pages: 11
Belongs to series: Contemporary Clinical Trials
ISSN: 1551-7144
URI: http://hdl.handle.net/10138/324540
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.
Subject: NAFLD
NASH
Cirrhosis
Biomarker
SCORING SYSTEM
STAGING SYSTEM
STEATOHEPATITIS
PROGRESSION
QUESTIONNAIRE
DEFINITIONS
CONSUMPTION
STEATOSIS
PROGNOSIS
ALGORITHM
317 Pharmacy
3111 Biomedicine
3121 General medicine, internal medicine and other clinical medicine
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