Population-based Study in Screening for Liver Fibrosis

Study Overview
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Brief Summary
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Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography

Detailed Description
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This is a population-based study. Subjects will attend a primary care center where a physical examination, general blood test and transient elastography will be carried out. Only the group of patients with high-risk for liver fibrosis will be evaluated in a second visit at the University Hospital.

Official Title
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Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.

Conditions
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Liver Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 40 years Able to give informed consent Exclusion Criteria: Previously known chronic liver disease (including cholestasis). Patients with already known liver steatosis but no diagnosis of liver fibrosis or cirrhosis can be included Subjects with mental incapacity, language barrier, insufficient social support or any other reason considered by the investigator precluding adequate understanding or cooperation in the study Subjects with a history of current malignancy including solid tumors and hematologic disorders Subjects with significant extrahepatic disease that may impair short-term prognosis (including congestive heart failure New York Heart Association Grade IV, COPD GOLD >3) Subjects with kidney disease (serum creatinine >3mg/dL or under renal replacement therapy)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- | --- |
| % of subjects with Liver stiffness measurement by Transient Elastography >=8 Kpa at any visit | Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8Kpa at any visit, either with M or XL probe, in general population. | Through study completion, an average of 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of subjects with Liver stiffness measurement by Transient Elastography >=8 Kpa in the subgroup of patients with risk factors for chronic liver disease at visit 1 or 2 | Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8Kpa, either with M or XL probe, in the subgroup of patients with risk factors for chronic liver disease at visit 1 and/or 2. | Through study completion, an average of 24 months | 
| Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores | Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores (including NAFLD fibrosis score, FIB-4, Forms index and APRI score) for the diagnosis of liver fibrosis in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and 2. | Through study completion, an average of 24 months | 
| Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy | Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy for the diagnosis of liver fibrosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with liver biopsy available at visit 2. | Through study completion, an average of 24 months | 
| % of subjects with CAP ≥250 dB/m2 | Percentage of subjects with CAP ≥250 dB/m2, either with M or XL probe, in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and/or 2 | Through study completion, an average of 24 months | 
| Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores | Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores (including FLI, HIS, LAP, ION and NAFLD-LFS) for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and 2. | Through study completion, an average of 24 months | 
| Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores and liver biopsy | Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores (including FLI, HIS, LAP, ION and NAFLD-LFS) and liver biopsy for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with liver biopsy available (at visit 2). | Through study completion, an average of 24 months | 
| Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound | Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with abdominal ultrasound available at visit 2. | Through study completion, an average of 24 months | 
| Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE | Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE at visit 2. | Through study completion, an average of 24 months | 
| Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population | Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population and in the subgroup of patients with risk factors for chronic liver disease. Direct and indirect cost savings of early detection of liver fibrosis in subjects with risk factors for chronic liver diseases. | Through study completion, an average of 24 months | 
| Percentage of failure rate for stiffness and steatosis measurements within TE examination | Percentage of failure rate for stiffness and steatosis measurements within TE examination at visit 1 and 2. | Through study completion, an average of 24 months | 
| Percentage of patients with procedure related adverse events and serious adverse events | Percentage of patients with procedure related adverse events (adverse events related to TE and liver biopsy) and serious adverse events during all the duration of the study. | Through study completion, an average of 24 months |