NCT05651724

Global Research Initiative for Patients Screening on MASH

Global Research Initiative for Patients Screening on MASH - Implementation of an International Transmural Patient Care Pathway

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Julius Clinical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• MASH
• MASLD
• MASH With Fibrosis
• Fibrosis, Liver
• Steatosis of Liver
• Type 2 Diabetes
• Obesity
• Metabolic Syndrome
• Arterial Hypertension

Timeline

• Start date: 2023-06-30
• Primary completion: 2031-03-31
• Completion: 2031-03-31
• First posted: 2022-12-15
• Last updated: 2024-08-01

Locations

13 sites across 10 countries: Belgium, Czechia, France, Germany, Greece, Italy, Netherlands, Portugal, Romania, Spain