Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease (NCT06523608) | Clinical Trial Compass
RecruitingNot Applicable
Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease
Germany600 participantsStarted 2024-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.