About this trial
Primary objective is to study the relevance of non-invasive test (NITs) in predicting disease stage (diagnostic biomarker) and outcome (predictive biomarker) in patients with suspected or established liver disease and cirrhosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Patient with historical liver biopsy providing histological evidence of any liver disease or,
Patient undergoing liver biopsy for suspected chronic liver disease with biochemical and/or radiological findings consistent with liver disease or,
Patient with clinical and radiological evidence of cirrhosis (in absence of an alternative aetiology)
Disqualifiers
Refusal or inability (lack of capacity) to give informed consent.
Age < 18 years
Pregnancy
An active malignancy.
Trial population
The study population will be patients (aged ≥18 years) with risk factors for chronic liver disease recruited at the I. Department of Medicine of the University Medical Center Mainz in Germany.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Overall survival
The primary objective of this observational study is to assemble a cohort of well-characterised patients with chronic liver disease (CLD) and to collect associated clinical information, biological samples and imaging data for cross-sectional and longitudinal analyses in order to robustly validate diagnostic and predictive non-invasive tests (NITs) for the diagnosis, risk assessment (prognosis) and monitoring of patients with liver disease. The primary outcome will be overall survival.
Secondary outcomes
Liver-related events
Longitudinal correlation of phenotype with liver -related outcome and transplant-free survival.
Other outcomes
Impact of liver disease on Quality of Life and Symptom-burden
* Study of symptom burden in patients with CLD (Quality of Life). * Study the underlying pathogenic processes contributing to disease progression in CLD
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johannes Gutenberg University Mainz
Lead sponsor
Boehringer Ingelheim
Collaborator
Nordic Bioscience A/S
Collaborator
This trial is not recruiting at the moment. You can still explore other options: