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

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 abou...

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Main Authors: Manuel Castro Cabezas, Joanne Verheij, Diederick E Grobbee, Marco Alings, Amalia Gastaldelli, Oscar H Franco, Vlad Ratziu, Helena Cortez-Pinto, Christophe Moreno, Jörn M Schattenberg, Jean W M Muris, Michail Doukas, Sven Francque, Luca Miele, Manuel Romero-Gómez, Lawrence Serfaty, José Willemse, Maarten E Tushuizen, Thomas Hankemeier, Céline Fournier-Poizat, Vivian D de Jong, Radan Bruha, George V Dedoussis, Adriaan G Holleboom, D Cristina Stefan
Format: Article
Language:English
Published: BMJ Publishing Group 2025-05-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/5/e092731.full
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author Manuel Castro Cabezas
Joanne Verheij
Diederick E Grobbee
Marco Alings
Amalia Gastaldelli
Oscar H Franco
Vlad Ratziu
Helena Cortez-Pinto
Christophe Moreno
Jörn M Schattenberg
Jean W M Muris
Michail Doukas
Sven Francque
Luca Miele
Manuel Romero-Gómez
Lawrence Serfaty
José Willemse
Maarten E Tushuizen
Thomas Hankemeier
Céline Fournier-Poizat
Vivian D de Jong
Radan Bruha
George V Dedoussis
Adriaan G Holleboom
D Cristina Stefan
author_facet Manuel Castro Cabezas
Joanne Verheij
Diederick E Grobbee
Marco Alings
Amalia Gastaldelli
Oscar H Franco
Vlad Ratziu
Helena Cortez-Pinto
Christophe Moreno
Jörn M Schattenberg
Jean W M Muris
Michail Doukas
Sven Francque
Luca Miele
Manuel Romero-Gómez
Lawrence Serfaty
José Willemse
Maarten E Tushuizen
Thomas Hankemeier
Céline Fournier-Poizat
Vivian D de Jong
Radan Bruha
George V Dedoussis
Adriaan G Holleboom
D Cristina Stefan
author_sort Manuel Castro Cabezas
collection DOAJ
description 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.
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spelling doaj-art-fb252c2a3bab4bd5a366fe209cda919a2025-08-20T01:59:14ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-092731Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre studyManuel Castro Cabezas0Joanne Verheij1Diederick E Grobbee2Marco Alings3Amalia Gastaldelli4Oscar H Franco5Vlad Ratziu6Helena Cortez-Pinto7Christophe Moreno8Jörn M Schattenberg9Jean W M Muris10Michail Doukas11Sven Francque12Luca Miele13Manuel Romero-Gómez14Lawrence Serfaty15José Willemse16Maarten E Tushuizen17Thomas Hankemeier18Céline Fournier-Poizat19Vivian D de Jong20Radan Bruha21George V Dedoussis22Adriaan G Holleboom23D Cristina Stefan243 Endocrinology, Erasmus MC, Rotterdam, The Netherlands5 Pathology, AMC, Amsterdam, Netherlands1 Department of Epidemiology, University Medical Centre Utrecht, Utrecht University, Utrecht, The NetherlandsDepartment of Cardiology, Amphia Hospital, Breda, The Netherlands8 Cardiometabolic Risk Laboratory, Institute of Clinical Physiology, CNR, Pisa, Italy1Department of Epidemiology, Erasmus MC—University Medical Center Rotterdam, Rotterdam, The Netherlands3 Institute of Cardiometabolism and Nutrition (ICAN), Paris, FranceClínica Universitária de Gastrenterologia, Laboratório de Nutrição, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal34 Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme and Laboratory of Experimental Gastroenterology, Université Libre de Bruxelles, Brussels, BelgiumMetabolic Liver Disease Research Program, I. Department of Internal Medicine, University Medical Center of the Johannes Gutenberg University, Mainz, GermanyFamily Medicine, Maastricht University, Research Institute CAPHRI, Maastricht, Limburg, The NetherlandsPathology, Erasmus MC Universitair Medisch Centrum Rotterdam, Rotterdam, Zuid-Holland, The Netherlands1 Gastroenterology Hepatology, University Hospital Antwerp, Edegem, Antwerp, Belgium5 Dipartimento Universitario Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, ItalyDigestive Diseases Unit and CIBERehd, Virgen Del Rocío University Hospital, Sevilla, Spain1Service d`Hépatologie and INSERM UMRS 938, Hôpital Saint Antoine, Université Pierre&Marie Curie, Paris, FranceDutch Liver Patients Association, Hoogland, The NetherlandsDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands14 Analytical Biosciences, Leiden Academic Centre for Drug Research, Leiden, The NetherlandsEchosens, Paris, FranceJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The NetherlandsGeneral University Hospital and the First Faculty of Medicine, Charles University, Praha, Czech RepublicDepartment of Nutrition and Dietetics, Harokopio University of Athens, Athens, GreeceDepartment of Vascular Medicine and Internal Medicine, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsMeric Global, Bucharest, RomaniaIntroduction 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.https://bmjopen.bmj.com/content/15/5/e092731.full
spellingShingle Manuel Castro Cabezas
Joanne Verheij
Diederick E Grobbee
Marco Alings
Amalia Gastaldelli
Oscar H Franco
Vlad Ratziu
Helena Cortez-Pinto
Christophe Moreno
Jörn M Schattenberg
Jean W M Muris
Michail Doukas
Sven Francque
Luca Miele
Manuel Romero-Gómez
Lawrence Serfaty
José Willemse
Maarten E Tushuizen
Thomas Hankemeier
Céline Fournier-Poizat
Vivian D de Jong
Radan Bruha
George V Dedoussis
Adriaan G Holleboom
D Cristina Stefan
Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study
BMJ Open
title Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study
title_full Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study
title_fullStr Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study
title_full_unstemmed Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study
title_short Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study
title_sort global research initiative for patient screening on mash griponmash protocol rationale and design of a prospective multicentre study
url https://bmjopen.bmj.com/content/15/5/e092731.full
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