Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study

. 2025 May 30 ; 15 (5) : e092731. [epub] 20250530

Jazyk angličtina Země Velká Británie, Anglie Médium electronic

Typ dokumentu protokol klinické studie, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid40447415

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

Clínica Universitária de Gastrenterologia Faculdade de Medicina Universidade de Lisboa Lisboa Portugal

Department of Gastroenterology and Hepatology Leiden University Medical Center Leiden Zuid Holland The Netherlands

Department of Gastroenterology Hepatopancreatology and Digestive Oncology Hopital Erasme Bruxelles Belgium

Department of Internal Medicine 2 Saarland University Hospital Homburg Saarland Germany

Department of Internal Medicine Franciscus Gasthuis en Vlietland Rotterdam Zuid Holland The Netherlands

Department of Nutrition and Dietetics Harokopio University of Athens Athens Greece

Department of Translational Medicine and Surgery Università Cattolica del Sacro Cuore Campus di Roma Roma Lazio Italy

Department of Vascular Medicine and Internal Medicine Amsterdam UMC Locatie AMC Amsterdam The Netherlands

Division of Gastroenterology and Hepatology University Hospital Antwerp Edegem Belgium

Echosens SA Paris France

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

ICAN Institute for Cardiometabolism and Nutrition Hôpital Pitié Salpêtrière Sorbonne University Paris France

Institute of Clinical Physiology National Research Council Pisa Italy

Julius Center for Health Sciences and Primary Care University Medical Center Utrecht Utrecht The Netherlands

Julius Clinical BV Zeist The Netherlands

Leiden Academic Centre for Drug Research Leiden University Leiden Zuid Holland The Netherlands

Liver Patients International Brussels Belgium

Liver Transplant Unit and Steatotic Liver Disease Clinic Digestive Disease Center CEMAD Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Lazio Italy

Meric Global Bucharest Romania

Pathology Amsterdam UMC Amsterdam The Netherlands

Pathology Erasmus MC Universitair Medisch Centrum Rotterdam Rotterdam Zuid Holland The Netherlands

Saarland University Saarbrucken Germany

UCM Digestive Diseases and SeLiver Group Virgen del Rocio University Hospital Institute of Biomedicine of Seville University of Seville Sevilla Andalucía Spain

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