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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| Nordic Bioscience A/S | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Liver-related events | Longitudinal correlation of phenotype with liver -related outcome and transplant-free survival. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of liver disease on Quality of Life and Symptom-burden |
| 5 years |
Inclusion Criteria:
Age ≥18 years
Clinically suspected chronic liver disease based on any of:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joern Schattenberg, Prof. Dr. | Contact | +49 (0) 6131 17 | 6074 | joern.schattenberg@unimedizin-mainz.de |
| Belinda Schröder, MSc | Contact | +49 (0) 6131 17 | 6075 | belinda.schroeder@unimedizin-mainz.de |
| Name | Affiliation | Role |
|---|---|---|
| Joern Schattenberg, Prof. Dr. | Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center of the Johannes Gutenber Univeristy | Mainz | 55131 | Germany |
The data and samples held by the Registry will be the property of the PI Prof. Jörn Schattenberg and the University Medical Center Mainz. Publication will be the responsibility of the PI in line with the polices established with partners in separate agreements and the requirements of the European Commission for open access publication. Scientific contributions will be duly and appropriately acknowledged in line with the 'Uniform Requirements for Articles Submitted to Biomedical Journals' produced by the Committee of Medical Journal Editors (2008).
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