NCT06523608 Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease
| NCT ID | NCT06523608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Muenster |
| Condition | Liver Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-09-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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).
Contact & Investigator
Jonel Trebicka, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
Department of Internal Medicine B, University Hospital Muenster, Muenster, Germany
Frequently Asked Questions
Who can join the NCT06523608 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06523608 currently recruiting?
Yes, NCT06523608 is actively recruiting participants. Contact the research team at jonel.trebicka@ukmuenster.de for enrollment information.
Where is the NCT06523608 trial being conducted?
This trial is being conducted at Münster, Germany.
Who is sponsoring the NCT06523608 clinical trial?
NCT06523608 is sponsored by University Hospital Muenster. The principal investigator is Jonel Trebicka, Prof. Dr. med. at Department of Internal Medicine B, University Hospital Muenster, Muenster, Germany. The trial plans to enroll 600 participants.