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Abstract Details |
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The European NAFLD registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease |
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Contemp Clin Trials. 2020 Oct 9;106175. doi: 10.1016/j.cct.2020.106175. Online ahead of print.
Timothy Hardy 1, Kristy Wonders 2, Ramy Younes 3, Guruprasad P Aithal 4, Rocio Aller 5, Michael Allison 6, Pierre Bedossa 2, Fay Betsou 7, Jerome Boursier 8, M Julia Brosnan 9, Alastair Burt 1, Jeremy Cobbold 10, Helena Cortez-Pinto 11, Chris P Day 1, Jean-Francois Dufour 12, Mattias Ekstedt 13, Sven Francque 14, Stephen Harrison 15, Luca Miele 16, Patrik Nasr 13, George Papatheodoridis 17, Salvatore Petta 18, Dina Tiniakos 19, Richard Torstenson 20, Luca Valenti 21, Adriaan G Holleboom 22, Hannele Yki-Jarvinen 23, Andreas Geier 24, Manuel Romero-Gomez 25, Vlad Ratziu 26, Elisabetta Bugianesi 27, Jörn M Schattenberg 28, Quentin M Anstee 29, LITMUS Consortium
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Author information
- 1Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.
- 2Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.
- 3Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; Division of Gastroenterology, Department of Medical Sciences, University of Torino, Torino, Italy.
- 4NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.
- 5Department of Gastroenterology, Clinic University Hospital, Medical School, University of Valladolid, Valladolid, Spain.
- 6Liver Unit, Department of Medicine, Cambridge NIHR Biomedical Research Centre, Cambridge University NHS Foundation Trust, United Kingdom.
- 7Integrated BioBank of Luxembourg (IBBL), 1, rue Louis Rech, L-3555, 3531 Dudelange, Luxembourg.
- 8Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire d'Angers, Angers, France; & Laboratoire HIFIH UPRES EA3859, Université d'Angers, Angers, France.
- 9Pfizer Inc., Cambridge, MA, USA.
- 10Department of Gastroenterology and Hepatology, Oxford NIHR Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
- 11Clínica Universitária de Gastrenterologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.
- 12Department of Hepatology and Clinical Research, University of Bern, Bern, Switzerland.
- 13Department of Gastroenterology and Hepatology, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
- 14Department of Gastroenterology Hepatology, Antwerp University Hospital, Belgium; Translational Sciences in Inflammation and Immunology, Laboratory of Experimental Medicine and Paediatrics, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
- 15Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
- 16Department of Translational Medicine and Surgery, Medical School, Università Cattolica del S. Cuore and Fondazione Pol. Gemelli IRCCS Hospital, Rome, Italy.
- 17Department of Gastroenterology, Medical School of National and Kapodistrian University of Athens, General Hospital of Athens "Laiko", Athens, Greece.
- 18Sezione di Gastroenterologia, Dipartimento Promozione della Salute, Materno-Infantile, di Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro", Università di Palermo, Palermo, Italy.
- 19Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; Department of Pathology, Aretaieion Hospital, National and Kapodistrian University of Athens, Athens, Greece.
- 20Allergan Marlow International, Buckinghamshire, UK.
- 21Department of Pathophysiology and Transplantation, University of Milan, Translational Medicine - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
- 22Department of Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, The Netherlands.
- 23University of Helsinki, Helsinki University Hospital, and Minerva Foundation Institute for Medical Research, Helsinki, Finland.
- 24Department of Hepatology, University of Würzburg, Würzburg, Germany.
- 25UCM Digestive Diseases, ciberehd and IBIS, Virgen del Rocío University Hospital, University of Seville, Seville, Spain.
- 26Sorbonne Université, Institute of Cardiometabolism and Nutrition, Pitié-Salpêtrière Hospital, Paris, France.
- 27Division of Gastroenterology, Department of Medical Sciences, University of Torino, Torino, Italy.
- 28Metabolic Liver Research Program, I. Department of Medicine, University Medical Centre, Mainz, Germany.
- 29Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom. Electronic address: quentin.anstee@newcastle.ac.uk.
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.
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