New liver risk scores aim to predict who needs closer monitoring
NCT ID NCT06523608
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing two scoring methods (PLEASE and M10S20) to see if they can better predict serious liver events, liver cancer, and death in 600 people with advanced chronic liver disease. Participants are randomly assigned to standard care or a risk-based monitoring schedule. The goal is to improve early detection and treatment without causing unnecessary visits.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients should be included in the study if they are hospitalized with suspected chronic liver liver disease of viral and/or steatotic origin.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital Muenster
RECRUITINGMünster, North Rhine-Westphalia, 48149, Germany
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