Predicting liver disease complications and cancer development in patients
Official title: Prediction of Decompensation and HCC Development in Patients With Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms
Run by University Hospital Muenster · NCT06523608 · Data updated 2026-11-12
This study is testing if a new way of monitoring patients with advanced liver disease can help predict serious health issues and cancer better than standard care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | University Hospital Muenster Academic / other |
| Locations | 1 site (Münster, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT06523608 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are hospitalized or outpatient individuals diagnosed with advanced chronic liver disease.
✕Probably not a fit
Patients with current malignancies, severe extra-hepatic diseases, or those under 18 years old may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to predict the short- and long-term risks of severe disease events, hepatocellular carcinoma (HCC), and mortality in patients with advanced chronic liver disease. Patients will be randomly assigned to either a control group, which follows standard clinical protocols, or a stratified surveillance program based on their risk levels determined by specific scoring systems. High-risk patients will receive more frequent monitoring and additional imaging tests, while low-risk patients will have less frequent follow-ups. The study also seeks to validate the cost-effectiveness of this risk stratification approach.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and early intervention for patients at high risk of liver disease complications and HCC.
How similar studies have gone: Other studies have shown promise in using risk stratification for monitoring liver disease, making this approach both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient admitted/referred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria) Exclusion Criteria: * Pregnancy * Age \<18 * Evidence of current malignancy except for non-melanocytic skin cancer * Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (New York Heart Association (NYHA) \> II); severe chronic pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease (GOLD) \> III), severe neurological and psychiatric disorders). * Human Immunodeficiency Virus (HIV) positive patients. * Previous liver or other transplantation. * Patients who decline to participate or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent. * Physician's denial (e.g. the investigator considers that the patient will not follow the protocol scheduled).
Where it's running
-
University Hospital Muenster
Münster, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Principal investigator: Jonel Trebicka, Prof. Dr. med. — Department of Internal Medicine B, University Hospital Muenster, Muenster, Germany
- Study coordinator: Jonel Trebicka, Prof. Dr. med.
- Email: jonel.trebicka@ukmuenster.de
- Phone: +49 02518359689
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.