Using Digital Twin Technology and Clinical Decision Support Systems to Improve the Early Detection, Personalised Treatment, and Long-term Monitoring of Patients Across the Full Spectrum of Metabolic-associated Fatty Liver Disease (MAFLD).

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute

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 volunteers

Qualifiers

- 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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Data recollection

    Other intervention

    Only data recollection for their use in the training, testing and early validation of computational models (but no other intervention) will be performed.

Treatment groups

7,720 Participants
are divided into 1 treatment group
Group A: ARTEMIs cohort1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From baseline assessment to last available follow-up (minimum 1 year, up to 5 years)

Secondary outcomes

1

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.

Time frame
Up to 5 years after baseline assessment

Other outcomes

1

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.

Time frame
From intervention to 1 year (TIPS) and up to 5 years (liver transplantation)
2

Cardiac complications associated with hepatocellular carcinoma treatments

Occurrence of cardiac-related adverse events following surgical, locoregional, or systemic treatments for hepatocellular carcinoma

Time frame
Up to 2 years after HCC treatment

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

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