Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Liver Disease
- Sponsor
- Johannes Gutenberg University Mainz
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Overall survival
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
Non-invasive tests (NITs) may complement and even reduce the need for liver biopsy in the diagnosis and follow up care of patients with chronic liver disease (CLD). NITs either include serum biomarkers (direct or indirect) or ultrasound-based tests, including vibration controlled transient elastography (VCTE), or a combination of both incorporated into several surrogate scores.
Investigators
Jörn M. Schattenberg
Prof. Dr.
Johannes Gutenberg University Mainz
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years
- •Clinically suspected chronic liver disease based on any of:
- •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)
- •Patients with metabolic risk factors predisposing to CLD
Exclusion Criteria
- •Refusal or inability (lack of capacity) to give informed consent.
- •Age \< 18 years
- •An active malignancy.
- •Life expectation of \< 5 years.
- •Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.
Outcomes
Primary Outcomes
Overall survival
Time Frame: 10 years
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(10 years)