Project name: GRIP on MASH: Global Research Initiative for Patient Screening on MASH

Project start date: 1. 12. 2023
Project completion date: 30. 11. 2027
Project Budget: a total of EUR 25,913,513.25 (of which EUR 673,476.00 for VFN)
Project guarantor: IV. internal clinic, prof. MD Radan Brůha, CSc.
Project Registration Number: 101132946

Project brief:

The project was supported by the EU Horizon EUROPE program and will be implemented by an international consortium including 27 public and private sector entities. The coordinator of the project is the University Medical Center Utrecht, Holland; VFN is one of the partners.

The goal of the project is to reduce the disease burden and comorbidities associated with metabolic steatotic liver disease (MASLD). MASLD is the most common chronic liver disease in economically developed countries. It mainly affects patients with metabolic syndrome, diabetes and overweight/obesity. With the increasing prevalence of the above diseases, MASLD is estimated to affect almost 50% of the adult population around 2040. The most risky is its advanced and progressive form - MASH (metabolic steatohepatitis), which is difficult to diagnose (need to perform a liver biopsy) and which is often accompanied by increased production and deposition of tissue in the liver (liver fibrosis). If MASH is not diagnosed and treated in time, the risk of progression to liver cirrhosis with all its complications increases significantly (hepatocellular carcinoma, bleeding in portal hypertension, liver insufficiency, etc.).

The goal of this project is to design a sustainable and scalable "GRIP on MASH" platform in cooperation with health technology manufacturers, pharmaceutical and biotech companies, which will enable a timely and affordable possibility to identify patients with MASLD and their better stratification, including non-invasive diagnosis of MASH. The platform will include AI-based decision support tools that will utilize existing and novel biomarkers/combinations of biomarkers. Their predictive accuracy will be tested at the primary care level. Activities will also include personalized lifestyle counseling, exploring evidence-based lifestyle elements and the effect of nutritional recommendations in the treatment of MASLD. The intention of the "GRIP on MASH" project is to change medical practice for patients with MASLD and reduce their burden. At the same time, it aims to reduce the socio-economic impact of MASLD on the health system, among other things, by early detection of the most at-risk patients, in whom medical intervention will enable a significant delay in late and, as a result, very costly complications of the disease.

IV. the VFN internal clinic in Prague will participate in the consortium in particular in the implementation of the clinical part of the project, the diagnosis of MASLD, the assessment of its severity (among other things, the performance of liver elastography measurements) and the collection of biological material. Part of the project is also the continuous raising of awareness of the MASLD issue within the lay and professional public (seminars, lectures, communication with primary care doctors) and ensuring the best possible availability of MASLD diagnostics in the Czech Republic.

Abstract in English:

GRIP on NASH will address the unmet public health need of reducing disease burden and comorbidities associated with non-alcoholic fatty liver disease (NAFLD). Together with seven medical technology, pharmaceutical and biotechnology companies, we will devise a sustainable and scalable GRIP on NASH Platform that will enable access to at-risk patients developing or having NAFLD through the early detection of this condition at the primary care level.

This Platform will allow A) the early detection of patients with NAFLD: distributed in 12 European Centers of Excellence (CoEs), 10,000 patients at high risk of NAFLD – defined as patients with type-2 diabetes mellitus, metabolic syndrome, obesity, or arterial hypertension – will be screened and characterized.

B) better patients' stratification: the Platform will include artificial intelligence-based decision support tools that will make use of existing and novel biomarkers/biomarker combinations. Their predictive accuracy will be tested at the primary care level; there we will perform multi-OMICs analysis (proteomics, lipidomics, metabolomics, genomics, metagenomics and fluxomics) in fasted blood samples and we will explore imaging biomarkers/organ-on-a-chip to find future non-invasive diagnostic alternatives for the current standard (liver biopsies).

C) personalized lifestyle advice, by exploring evidence-based lifestyle features and the effect of nutritional recommendations: among the cohorts at the CoEs, we will use validated questionnaires to assess physical activity, diet, sleep, smoking, alcohol consumption, and perception of stress . Integrating patients' perspectives with the participation of three patient organizations, the trustworthiness, and sustainability of our GRIP on NASH Platform will be assessed by investigating potential economic, ethical, and regulatory barriers to its future adoption. GRIP on NASH will change healthcare practice in NAFLD and reduce the disease burden for patients.

Links and other materials:

• Coordinator's press release to launch the project