Chronic Liver Disease
Conditions
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Nordic Bioscience A/S
Johannes Gutenberg University Mainz
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Inclusion criteria
1. Age ≥18 years 2. Clinically suspected chronic liver disease based on any of: 1. Patient with historical liver biopsy providing histological evidence of any liver disease or, 2. Patient undergoing liver biopsy for suspected chronic liver disease with biochemical and/or radiological findings consistent with liver disease or, 3. Patient with clinical and radiological evidence of cirrhosis (in absence of an alternative aetiology) 4. Patients with metabolic risk factors predisposing to CLD
Exclusion criteria
1. Refusal or inability (lack of capacity) to give informed consent. 2. Age \< 18 years 3. Pregnancy 4. An active malignancy. 5. Life expectation of \< 5 years. 6. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Liver-related events | 10 years | Longitudinal correlation of phenotype with liver -related outcome and transplant-free survival. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Impact of liver disease on Quality of Life and Symptom-burden | 5 years | * Study of symptom burden in patients with CLD (Quality of Life). * Study the underlying pathogenic processes contributing to disease progression in CLD |
Countries
Germany
Contacts
Primary ContactJoern Schattenberg, Prof. Dr.
Backup ContactBelinda Schröder, MSc
Outcome results
None listed