Population-based Study in Screening for Liver Fibrosis
LiverScreen
Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.
1 other identifier
observational
30,000
9 countries
45
Brief Summary
Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Longer than P75 for all trials
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2018
CompletedFirst Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
December 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2025
CompletedJanuary 17, 2025
January 1, 2025
6.6 years
November 14, 2018
January 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
% 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
Secondary Outcomes (12)
% 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
Through study completion, an average of 24 months
Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores
Through study completion, an average of 24 months
Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy
Through study completion, an average of 24 months
% of subjects with CAP ≥250 dB/m
Through study completion, an average of 24 months
Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores
Through study completion, an average of 24 months
- +7 more secondary outcomes
Eligibility Criteria
General population above 40 years
You may qualify if:
- Age ≥ 40 years
- Able to give informed consent
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Dubrava Hospital
Zagreb, 10000, Croatia
Poliklinika Croatia
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
Padua, Italy
Vigonza Medica
Padua, 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
Related Publications (1)
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.
PMID: 35854275DERIVED
Biospecimen
Plasma and serum specimens will be retained in a repository
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pere Ginès, MD
Fundacion Clinic per a la Recerca Biomédica
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Research Manager
Study Record Dates
First Submitted
November 14, 2018
First Posted
December 31, 2018
Study Start
March 19, 2018
Primary Completion
November 7, 2024
Study Completion
January 7, 2025
Last Updated
January 17, 2025
Record last verified: 2025-01