Περίληψη:
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. © 2020 The Author(s)
Συγγραφείς:
Hardy, T.
Wonders, K.
Younes, R.
Aithal, G.P.
Aller, R.
Allison, M.
Bedossa, P.
Betsou, F.
Boursier, J.
Brosnan, M.J.
Burt, A.
Cobbold, J.
Cortez-Pinto, H.
Day, C.P.
Dufour, J.-F.
Ekstedt, M.
Francque, S.
Harrison, S.
Miele, L.
Nasr, P.
Papatheodoridis, G.
Petta, S.
Tiniakos, D.
Torstenson, R.
Valenti, L.
Holleboom, A.G.
Yki-Jarvinen, H.
Geier, A.
Romero-Gomez, M.
Ratziu, V.
Bugianesi, E.
Schattenberg, J.M.
Anstee, Q.M.
on behalf of the LITMUS Consortium
Λέξεις-κλειδιά:
biological marker; genomic DNA, adult; Article; cohort analysis; disease exacerbation; histopathology; human; information processing; international physical activity questionnaire; liver biopsy; liver cirrhosis; liver fibrosis; longitudinal study; medical ethics; nonalcoholic fatty liver; Nonalcoholic Fatty Liver Disease Activity Score; protocol compliance; publication; quality of life; sample; scoring system; sedentary lifestyle; liver; liver cirrhosis; liver tumor; non insulin dependent diabetes mellitus; nonalcoholic fatty liver; pathology; register, Cohort Studies; Diabetes Mellitus, Type 2; Humans; Liver; Liver Cirrhosis; Liver Neoplasms; Longitudinal Studies; Non-alcoholic Fatty Liver Disease; Registries
