Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.

Conditions
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Chronic Liver Disease

Participation Criteria
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Eligibility Criteria
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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 Pregnancy 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-sectional correlation of clinical phenotype data with non-invasive tests to develop and validate optimum biomarker approaches for the diagnosis and risk stratification of CLD. | 1. 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2The secondary objectives are to explore the pathophysiology of chronic liver disease using a range of starte-of-the-art scientific techniques and an integrated data-analysis approach. | Longitudinal correlation of clinical phenotype data with blood-based biomarkers (genetic, epigenetic, transcriptomic, metabolomics, proteomic and metagenomic) and/or imaging biomarkers to develop and validate optimum biomarker approaches for the diagnosis, risk stratification and monitoring of CLD. Study of symptom burden in patients with CLD (Quality of Life). Study the underlying pathogenic processes contributing to disease progression in CLD | 3 years |