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

Hardy, Timothy; Wonders, Kristy; Younes, Ramy; Aithal, Guruprasad P; Aller, Rocio; Allison, Michael; Bedossa, Pierre; Betsou, Fay; Boursier, Jerome; Brosnan, M Julia; Burt, Alastair; Cobbold, Jeremy; Cortez-Pinto, Helena; Day, Chris P; Dufour, Jean-François; Ekstedt, Mattias; Francque, Sven; Harrison, Stephen; Miele, Luca; Nasr, Patrik; ... (2020). The European NAFLD Registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease. Contemporary clinical trials, 98, p. 106175. Elsevier 10.1016/j.cct.2020.106175

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Hepatology
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Hepatologie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Hepatologie

UniBE Contributor:

Dufour, Jean-François

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1551-7144

Publisher:

Elsevier

Language:

English

Submitter:

Thi Thao Anh Pham

Date Deposited:

09 Dec 2020 16:03

Last Modified:

13 Mar 2021 12:21

Publisher DOI:

10.1016/j.cct.2020.106175

PubMed ID:

33045403

Uncontrolled Keywords:

Biomarker Cirrhosis NAFLD NASH

BORIS DOI:

10.7892/boris.148104

URI:

https://boris.unibe.ch/id/eprint/148104

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