About this trial
The goal of this observational study is to create a detailed virtual model to better understand how Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) develops. This model will also help predict heart problem at different stage of the disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
- Clinical Use Case 1: Liver disease staging in MASLD patients - Prediction model of fibrosis changes (progression and regression), with ability to distinguish between fast and non-fast fibrosis progression among MASLD patients.
Age ≥18 years
Diagnosis of MASLD confirmed by radiological imaging (any type: MR, CT, PET, VCTE, US, USE...) or histology (gold standard, following MASH SAF score)
With at least one follow-up of minimum 1 year after diagnosis of MASLD, with radiological imaging or histology
Disqualifiers
- Clinical Use Case 1: Liver disease staging in MASLD patients - Prediction model of fibrosis changes (progression and regression), with ability to distinguish between fast and non-fast fibrosis progression among MASLD patients.
Missing data on blood glucose, BMI and metabolic status.
Patients who have received systemic chemotherapy
Patients with hepatitis B (HBV) and hepatitis C (HCV), alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 30g / D in male and ≥ 20g / D in female), drug-induced liver disease or autoimmune hepatitis.
Trial population
The study population description involve a retrospective collection and analysis of health data obtained from individual patients or healthy persons. Patients along the MASLD spectrum will be recruited in 12 participant sites. A researcher will select cases fulfilling the inclusion and exclusion criteria and process them according to the Project work plan.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Data recollection
Other interventionOnly data recollection for their use in the training, testing and early validation of computational models (but no other intervention) will be performed.
Treatment groups
Trial outcomes
Primary outcomes
Liver disease progression and regression in MASLD patients
Probability rates of liver disease progression or regression in MASLD patients, including fibrosis stage changes and development of steatohepatitis (MASH), assessed using validated non-invasive tests, imaging techniques, and liver histology when available
Secondary outcomes
Incidence of cardiovascular events in MASLD patients
Occurrence of cardiovascular events including myocardial infarction, stroke, atrial fibrillation, and heart failure in MASLD patients during retrospective follow-up.
Other outcomes
Cardiovascular complications following TIPS placement or liver transplantation
Incidence of cardiac events, including heart failure, myocardial infarction, symptomatic coronary heart disease, and arrhythmias, in patients with cirrhosis undergoing TIPS placement or liver transplantation.
Cardiac complications associated with hepatocellular carcinoma treatments
Occurrence of cardiac-related adverse events following surgical, locoregional, or systemic treatments for hepatocellular carcinoma
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Universitari Vall d'Hebron Research Institute
Lead sponsor
Matical Innovation SL
Collaborator
Assistance Publique - Hôpitaux de Paris
Collaborator
Jena University Hospital
Collaborator
Institut National de Recherche en Informatique et en Automatique
Collaborator
German Cancer Research Center
Collaborator
MEDEX
Collaborator
EUROPEAN LIVER PATIENTS ASSOCIATION
Collaborator
Betthera s.r.o.
Collaborator
Bournemouth University
Collaborator
University Hospital Heidelberg
Collaborator
Fundacion Para La Investigacion Hospital La Fe
Collaborator
University of Roma La Sapienza
Collaborator
Charite University, Berlin, Germany
Collaborator
Medical University of Vienna
Collaborator
Saint-Luc University Hospital
Collaborator
University of Freiburg
Collaborator
University of Leipzig
Collaborator
Sheba Medical Center
Collaborator
Imperial College London
Collaborator
This trial is not recruiting at the moment. You can still explore other options: