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Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study
VD. de Jong, M. Alings, R. Bruha, H. Cortez-Pinto, GV. Dedoussis, M. Doukas, S. Francque, C. Fournier-Poizat, A. Gastaldelli, T. Hankemeier, AG. Holleboom, L. Miele, C. Moreno, JWM. Muris, V. Ratziu, M. Romero-Gomez, JM. Schattenberg, L. Serfaty,...
Language English Country England, Great Britain
Document type Clinical Trial Protocol, Journal Article
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- MeSH
- Diabetes Mellitus, Type 2 complications MeSH
- Liver Cirrhosis diagnosis MeSH
- Humans MeSH
- Metabolic Syndrome complications MeSH
- Multicenter Studies as Topic MeSH
- Non-alcoholic Fatty Liver Disease * diagnosis MeSH
- Mass Screening * methods MeSH
- Prospective Studies MeSH
- Research Design MeSH
- Fatty Liver * diagnosis epidemiology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
INTRODUCTION: The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) may be as high as 38% in the adult population with potential serious complications, multiple comorbidities and a high socioeconomic burden. However, there is a general lack of awareness and knowledge about MASLD and its progressive stages (metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis). Therefore, MASLD is still far underdiagnosed. The 'Global Research Initiative for Patient Screening on MASH' (GRIPonMASH) consortium focuses on this unmet public health need. GRIPonMASH will help (primary) healthcare providers to implement a patient care pathway, as recommended by multiple scientific societies, to identify patients at risk of severe MASLD and to raise awareness. Furthermore, GRIPonMASH will contribute to a better understanding of the pathophysiology of MASLD and improved identification of diagnostic and prognostic markers to detect individuals at risk. METHODS: This is a prospective multicentre observational study in which 10 000 high-risk patients (type 2 diabetes mellitus, obesity, metabolic syndrome or hypertension) will be screened in 10 European countries using at least two non-invasive tests (Fibrosis-4 index and FibroScan). Blood samples and liver biopsy material will be collected and biobanked, and multiomics analyses will be conducted. ETHICS AND DISSEMINATION: The study will be conducted in compliance with this protocol and applicable national and international regulatory requirements. The study initiation package is submitted at the local level. The study protocol has been approved by local medical ethical committees in all 10 participating countries. Results will be made public and published in scientific, peer-reviewed, international journals and at international conferences. REGISTRATION DETAILS: NCT05651724, registration date: 15 Dec 2022.
Cardiology Amphia Hospital Breda The Netherlands
Department of Internal Medicine 2 Saarland University Hospital Homburg Saarland Germany
Department of Nutrition and Dietetics Harokopio University of Athens Athens Greece
Division of Gastroenterology and Hepatology University Hospital Antwerp Edegem Belgium
Endocrinology Erasmus University Medical Center Rotterdam The Netherlands
Family Medicine Maastricht University Maastricht The Netherlands
General University Hospital and the 1st Faculty of Medicine Charles University Praha Czech Republic
Hôpitaux Universitaires de Strasbourg Strasbourg France
Institute of Clinical Physiology National Research Council Pisa Italy
Julius Clinical BV Zeist The Netherlands
Leiden Academic Centre for Drug Research Leiden University Leiden Zuid Holland The Netherlands
Liver Patients International Brussels Belgium
Meric Global Bucharest Romania
Pathology Amsterdam UMC Amsterdam The Netherlands
Pathology Erasmus MC Universitair Medisch Centrum Rotterdam Rotterdam Zuid Holland The Netherlands
References provided by Crossref.org
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