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Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography
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.
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| 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 ≥ 8 kPa at any visit, either with M or XL probe, in general population. | Through study completion, an average of 24 months |
| 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 ≥ 8 kPa, 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 |
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Inclusion Criteria:
Exclusion Criteria:
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General population above 40 years
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| Name | Affiliation | Role |
|---|---|---|
| Pere Ginès, MD | Fundacion Clinic per a la Recerca Biomédica | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dubrava Hospital | Zagreb | 10000 | Croatia | |||
| Poliklinika Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35854275 | Derived | Graupera I, Thiele M, Ma AT, Serra-Burriel M, Pich J, Fabrellas N, Caballeria L, de Knegt RJ, Grgurevic I, Reichert M, Roulot D, Schattenberg JM, Pericas JM, Angeli P, Tsochatzis EA, Guha IN, Garcia-Retortillo M, Morillas RM, Hernandez R, Hoyo J, Fuentes M, Madir A, Juanola A, Soria A, Juan M, Carol M, Diaz A, Detlefsen S, Toran P, Pera G, Fournier C, Llorca A, Newsome PN, Manns M, de Koning HJ, Serra-Burriel F, Cucchietti F, Arslanow A, Korenjak M, van Kleef L, Falco JL, Kamath PS, Karlsen TH, Castera L, Lammert F, Krag A, Gines P; LiverScreen Consortium investigators. LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries. BMC Public Health. 2022 Jul 19;22(1):1385. doi: 10.1186/s12889-022-13724-6. |
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Plasma and serum specimens will be retained in a repository
| 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/m | Percentage of subjects with CAP ≥250 dB/m, 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 |
| Percentage of patients with changes in lifestyle habits | Percentage of patients with changes in lifestyle habits | Through study completion, an average of 24 months |
| Zagreb |
| 1000 |
| Croatia |
| Odense University Hospital | Odense | Denmark |
| Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers | Gennevilliers | 92230 | France |
| Centre de Recherche Clinique - CRC | Paris | France |
| Hospital Avicenne | Paris | France |
| Hospital Beaujon | Paris | France |
| Homburg Hospital | Homburg | Germany |
| Altstadtpraxis | Mainz | Germany |
| Mainz Hospital | Mainz | Germany |
| Praxis Mombach | Mainz | Germany |
| MVZ Dres.Schneider Kaiserslautern | Rodenbach | Germany |
| Medicina Di gruppo di montagnana | Padova | Italy |
| Vigonza Medica | Padova | Italy |
| Medical Center Rotterdam | Rotterdam | Netherlands |
| F. D. Roosevelt Univ. Hospital | Banská Bystrica | Slovakia |
| Hospital Germans Trias i Pujol | Badalona | Barcelona | Spain |
| SEAT | Martorell | Barcelona | 08760 | Spain |
| CAP II El Maresme | Mataró | Barcelona | Spain |
| CAP II Santa Coloma de Gramanet | Santa Coloma de Gramenet | Barcelona | Spain |
| CAP La Florida | Santa Perpètua de Mogoda | Barcelona | Spain |
| CAP Barceloneta | Barcelona | 08003 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| CAP Bordeta-Magòria | Barcelona | 08014 | Spain |
| CAP Río de Janeiro | Barcelona | 08016 | Spain |
| CAP Ciutat Meridiana | Barcelona | 08033 | Spain |
| CAP Sant Rafael | Barcelona | 08035 | Spain |
| Hospital Universirati Vall d'Hebrón | Barcelona | 08035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| CAP Adrià | Barcelona | Spain |
| CAP Besos | Barcelona | Spain |
| CAP La Marina | Barcelona | Spain |
| CAP Numància | Barcelona | Spain |
| CAP Vila de Gracia | Barcelona | Spain |
| CAP Vila Olimpica | Barcelona | Spain |
| Hospital Gregorio Marañon | Madrid | Spain |
| CAP La Llantia | Mataró | Spain |
| Oak Lodge Medical Centre | Edgware | HA8 0AP | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| James Wigg | London | United Kingdom |
| Mild May | London | United Kingdom |
| Oakleigh park | London | United Kingdom |
| St Andrews Medical Practice | London | United Kingdom |
| Nottingham University Hospital | Nottingham | NG5 1PB | United Kingdom |
| King's Mill Hospital | Sutton in Ashfield | NG17 4JL | United Kingdom |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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