GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.
GRIPonMASH is an observational study in which 10.000 high risk patients (type 2 diabetes mellitus, metabolic syndrome, obesity or arterial hypertension) in 10 different European countries will be screened for the presence of MASLD, liver fibrosis and (at-rsik) MASH using at least two non-invasive tests (FIB-4 and FibroScan). Additional published and exploratory non-invasive test will also be investigated. Blood samples and liver biopsy material will be collected. Genomic, proteomic, metabolomic, lipidomic and fluxomic studies will be applied to gain a better understanding of the pathophysiology of MASLD and to identify (bio)markers that will help to detect patients at-risk. The predictive value of FIB-4 in relation to FibroScan results and liver biopsy will be analysed. Long-term follow-up of 5 years in all participants will provide insight into the natural history of the disease.
Study Type
OBSERVATIONAL
Enrollment
10,000
Hôpital Erasme, Cliniques Universitaires De Bruxelles
Brussels, Vlaams-brabant, Belgium
RECRUITINGAntwerp University Hospital
Antwerp, Belgium
ACTIVE_NOT_RECRUITING4th internal clinic General University Hospital
Prague, Bohemia, Czechia
NOT_YET_RECRUITINGHôpital de la Pitié Salpêtrière
Paris, Il-de-France, France
NOT_YET_RECRUITINGUniversitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany
RECRUITINGUniversitätsklinikum des Saarlandes
Homburg, Saarland, Germany
NOT_YET_RECRUITINGHarokopio University of Athens
Athens, Greece
NOT_YET_RECRUITINGFondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC)
Rome, Lazio, Italy
NOT_YET_RECRUITINGAmsterdam UMC
Amsterdam, South Holland, Netherlands
RECRUITINGFranciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands
RECRUITING...and 3 more locations
Prevalence of liver steatosis and MASLD estimated by FibroScan CAP in patients at risk
Steatosis grade deduced from controlled attenuation parameter (CAP) measurement with Fibroscan
Time frame: Baseline
Prevalence of liver fibrosis estimated by FibroScan LSM in patients at risk
Fibrosis stage deduced from liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) measurement with Fibroscan
Time frame: Baseline
Prevalence of at-risk MASH estimated by FAST score in patients at risk
At-risk MASH deduced from FAST score
Time frame: Baseline
*Subset of patients: prevalence of MASH in patients at risk
MASH diagnosis confirmed by histology (NAS/SAF criteria) upon liver biopsy; only in patients with \>12 kPa at 1st FibroScan or \>=8 kPa at 2nd FibroScan
Time frame: 16 or 30 weeks
Comparison of the prevalence of MASLD, liver fibrosis and (at-risk) MASH between the participating countries
Prevalence (see outcome 1-4) stratified per country
Time frame: Baseline (1-3) to 16/30 weeks for biopsy-confirmed MASH (4)
Evaluate added value of a 2-step pathway as compared to FibroScan only for detection of high-risk patients
Number of patients at risk identified by FIB-4 compared to numbers found using LSM by VCTE with FibroScan measurements, and numbers found in combination
Time frame: Baseline
Build diagnostic model to identify MASH patients in a high-risk population
Possible model parameters are all baseline clinical characteristics reported in the eCRF
Time frame: Baseline
Genotypes related to MASH in different European countries: Exploratory
Genomic (GWAS) and proteomic analysis on collected blood samples
Time frame: Baseline
(Non-invasive) metabolite biomarkers identifying MASH in patients at risk: Exploratory
Mass-spectrometry (MS) based metabolomic and lipidomic analyses on collected blood and samples, both targeted and untargeted approaches.
Time frame: Baseline
Prevalence of co-morbidities and associated therapies (especially for CVD) in patients with MASH compared to those without, in high-risk patient populations
Prevalence of comorbidities, medication use, medical history
Time frame: Baseline
Identify prognostic factors/biomarkers for complications in patients with MASLD and MASH by 5 years follow up
Disease progression and liver-related and non-liver related complications
Time frame: Throughout follow-up (at 3 and 5 years)
Patient Reported Outcomes: Dietary habits and lifestyle
14 item Mediterranean Diet Score; lifestyle surveys
Time frame: Baseline + throughout follow-up (at 3 and 5 years)
*Subset of patients: Second FibroScan examination
CAP and LSM by VCTE at 2nd FibroScan examination
Time frame: 14 weeks
Longitudinal changes in liver assessments
Repeated CAP, LSM by VCTE and FAST measurements over time
Time frame: Baseline, 14 weeks + throughout follow-up (at 3 and 5 years)
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