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

被引：98

作者：

Hardy, Timothy ^{[1
,2
]}

Wonders, Kristy ^{[1
]}

Younes, Ramy ^{[1
,3
]}

Aithal, Guruprasad P. ^{[4
,5
]}

Aller, Rocio ^{[6
]}

Allison, Michael ^{[7
]}

Bedossa, Pierre ^{[1
]}

Betsou, Fay ^{[8
]}

Boursier, Jerome ^{[10
]}

Brosnan, M. Julia ^{[11
]}

Burt, Alastair ^{[1
,2
]}

Cobbold, Jeremy ^{[9
,12
]}

Cortez-Pinto, Helena ^{[13
]}

Day, Chris P. ^{[1
,2
]}

Dufour, Jean-Francois ^{[14
]}

Ekstedt, Mattias ^{[15
]}

Francque, Sven ^{[16
,17
]}

Harrison, Stephen ^{[18
]}

Miele, Luca ^{[19
,20
]}

Nasr, Patrik ^{[15
]}

Papatheodoridis, George ^{[21
]}

Petta, Salvatore ^{[22
]}

Tiniakos, Dina ^{[23
]}

Torstenson, Richard ^{[24
]}

Valenti, Luca ^{[25
]}

Holleboom, Adriaan G. ^{[26
]}

Yki-Jarvinen, Hannele ^{[27
,28
]}

Geier, Andreas ^{[29
]}

Romero-Gomez, Manuel ^{[30
]}

Ratziu, Vlad ^{[31
]}

Bugianesi, Elisabetta ^{[3
]}

Schattenberg, Jorn M. ^{[32
]}

Anstee, Quentin M. ^{[1
,2
]}

机构：

[1] Newcastle Univ, Fac Med Sci, Translat & Clin Res Inst, 4th Floor William Leech Bldg,Framlington Pl, Newcastle Upon Tyne NE2 4HH, Tyne & Wear, England

[2] Newcastle Tyne Hosp NHS Fdn Trust, Newcastle NIHR Biomed Res Ctr, Newcastle Upon Tyne, Tyne & Wear, England

[3] Univ Torino, Dept Med Sci, Div Gastroenterol, Turin, Italy

[4] Nottingham Univ Hosp NHS Trust, NIHR Nottingham Biomed Res Ctr, Nottingham, England

[5] Univ Nottingham, Nottingham, England

[6] Univ Valladolid, Med Sch, Clin Univ Hosp, Dept Gastroenterol, Valladolid, Spain

[7] Cambridge Univ NHS Fdn Trust, Cambridge NIHR Biomed Res Ctr, Dept Med, Liver Unit, Cambridge, England

[8] Integrated BioBank Luxembourg IBBL, 1 Rue Louis Rech, L-3555 Dudelange, Luxembourg

[9] CHU Angers, Serv Hepatogastroenterol, Angers, France

[10] Univ Angers, Lab HIFIH UPRES EA3859, Angers, France

[11] Pfizer Inc, Cambridge, MA USA

[12] Oxford Univ Hosp NHS Fdn Trust, Oxford NIHR Biomed Res Ctr, Dept Gastroenterol & Hepatol, Oxford, England

[13] Univ Lisbon, Fac Med, Clin Univ Gastrenterol, Lisbon, Portugal

[14] Univ Bern, Dept Hepatol & Clin Res, Bern, Switzerland

[15] Linkoping Univ, Dept Hlth Med & Caring Sci, Dept Gastroenterol & Hepatol, Linkoping, Sweden

[16] Antwerp Univ Hosp, Dept Gastroenterol Hepatol, Antwerp, Belgium

[17] Univ Antwerp, Fac Med & Hlth Sci, Lab Expt Med & Paediat, Translat Sci Inflammat & Immunol, Antwerp, Belgium

[18] Univ Oxford, Radcliffe Dept Med, Oxford, Japan

[19] Univ Cattolica S Cuore, Med Sch, Dept Translat Med & Surg, Rome, Italy

[20] Fdn Pol Gemelli IRCCS Hosp, Rome, Italy

[21] Natl & Kapodistrian Univ Athens, Med Sch, Dept Gastroenterol, Gen Hosp Athens Laiko, Athens, Greece

[22] Univ Palermo, Dipartimento Promoz Salute Maternoinfantile Med I, Sez Gastroenterol, Palermo, Italy

[23] Natl & Kapodistrian Univ Athens, Dept Pathol, Aretaie Hosp, Athens, Greece

[24] Allergan Marlow Int, Marlow, Bucks, England

[25] Univ Milan, Translat Med Fdn IRCCS Ca Granda Osped Maggiore, Dept Pathophysiol & Transplantat, Milan, Italy

[26] Univ Amsterdam, Med Ctr, Dept Vasc Med, Amsterdam, Netherlands

[27] Univ Helsinki, Helsinki Univ Hosp, Helsinki, Finland

[28] Minerva Fdn, Helsinki, Finland

[29] Univ Wurzburg, Dept Hepatol, Wurzburg, Germany

[30] Univ Seville, Virgen Rocio Univ Hosp, UCM Digest Dis, Ciberehd & IBIS, Seville, Spain

[31] Sorbonne Univ, Inst Cardiometab & Nutr, Pitie Salpetriere Hosp, Paris, France

[32] Univ Med Ctr, Dept Med 1, Metab Liver Res Program, Mainz, Germany

来源：

CONTEMPORARY CLINICAL TRIALS | 2020年 / 98卷

基金：

欧盟地平线“2020”;

关键词：

NAFLD; NASH; Cirrhosis; Biomarker; SCORING SYSTEM; STAGING SYSTEM; STEATOHEPATITIS; PROGRESSION; QUESTIONNAIRE; DEFINITIONS; CONSUMPTION; STEATOSIS; PROGNOSIS; ALGORITHM;

D O I：

10.1016/j.cct.2020.106175

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：11

共 42 条

[41] The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe [J].