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

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 design

Treatments tested in this trial

  • Data recollection

Treatment groups

7,720 Participants
are divided into 1 treatment group

Sponsors and collaborators

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