NCT06523608Recruiting
Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease
Prediction of Decompensation and HCC Development in Patients With Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
The aim of this observational study is to predict the short- and long-term development of acute severe disease events, de novo hepatocarcinoma (HCC) and mortality in patients with advanced chronic liver disease using the M10S20 (Liver stiffness and Model for End-Stage Liver Disease Score \[MELD\] combined) and PLEASE (Platelet, Etiology, Age, Sex und Elastography) scores, as well as the validation of the cost-effectiveness of the algorithm. Patients in this study are randomly divided into two groups: * Control group: patients are examined according to the current clinical standard protocol (biannual follow-up). * Stratified surveillance program: * High-risk patients will receive an appointment for a hospital visit every 3 months. * Low-risk patients could receive an appointment in one year. When necessary, if decompensation develops or HCC occurs, patients could be followed-up more frequently.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 15 Jul 2024
- Start date
- 1 Sept 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- University Hospital Muenster
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06523608
What you commit to
- Study type: Observational
- Planned participants: 600
- From 1 Sept 2024 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Age
- Age \<18
Other
- Pregnancy
- Physician's denial (e.g. the investigator considers that the patient will not follow the protocol scheduled).
Who the study is looking for
- The patient admitted/referred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University hospital Muenster Coordinator of this site? Confirm its status | Münster | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.