- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03789825
Population-based Study in Screening for Liver Fibrosis (LiverScreen)
September 15, 2022 updated by: Judit Pich Martínez
Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.
Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
20000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zagreb, Croatia, 10000
- Dubrava Hospital
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Zagreb, Croatia, 1000
- Poliklinika Croatia
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Odense, Denmark
- Odense University Hospital
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Gennevilliers, France, 92230
- Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers
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Paris, France
- Centre de Recherche Clinique - CRC
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Paris, France
- Hospital AVICENNE
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Paris, France
- Hospital Beaujon
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Homburg, Germany
- Homburg Hospital
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Mainz, Germany
- Mainz Hospital
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Rodenbach, Germany
- MVZ Dres.Schneider Kaiserslautern
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Rotterdam, Netherlands
- Medical Center Rotterdam
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Barcelona, Spain, 08003
- Hospital del Mar
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Barcelona, Spain, 08003
- CAP Barceloneta
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Barcelona, Spain, 08014
- CAP Bordeta-Magòria
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Barcelona, Spain, 08016
- CAP Río de Janeiro
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Barcelona, Spain, 08033
- CAP Ciutat Meridiana
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Barcelona, Spain, 08035
- CAP Sant Rafael
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Barcelona, Spain, 08035
- Hospital Universirati Vall d'Hebrón
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Barcelona, Spain
- CAP Adrià
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Barcelona, Spain
- CAP La Marina
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Barcelona, Spain
- CAP Numància
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Barcelona
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Badalona, Barcelona, Spain
- Hospital Germans Trias i Pujol
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Martorell, Barcelona, Spain, 08760
- SEAT
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Mataró, Barcelona, Spain
- CAP II El Maresme
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Santa Coloma De Gramenet, Barcelona, Spain
- CAP II Santa Coloma de Gramanet
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Santa Perpètua De Mogoda, Barcelona, Spain
- CAP La Florida
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Edgware, United Kingdom, HA8 0AP
- Oak Lodge Medical Centre
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London, United Kingdom, NW3 2QG
- Royal Free Hospital
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London, United Kingdom
- St Andrews Medical Practice
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Nottingham, United Kingdom, NG5 1PB
- Nottingham University Hospital
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Sutton In Ashfield, United Kingdom, NG17 4JL
- King's Mill Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
General population above 40 years
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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% of subjects with Liver stiffness measurement by Transient Elastography >=8 Kpa at any visit
Time Frame: Through study completion, an average of 24 months
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Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8Kpa at any visit, either with M or XL probe, in general population.
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Through study completion, an average of 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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% 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
Time Frame: Through study completion, an average of 24 months
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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.
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Through study completion, an average of 24 months
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Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores
Time Frame: Through study completion, an average of 24 months
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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.
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Through study completion, an average of 24 months
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Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy
Time Frame: Through study completion, an average of 24 months
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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.
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Through study completion, an average of 24 months
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% of subjects with CAP ≥250 dB/m2
Time Frame: Through study completion, an average of 24 months
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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
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Through study completion, an average of 24 months
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Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores
Time Frame: Through study completion, an average of 24 months
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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.
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Through study completion, an average of 24 months
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Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores and liver biopsy
Time Frame: Through study completion, an average of 24 months
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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).
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Through study completion, an average of 24 months
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Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound
Time Frame: Through study completion, an average of 24 months
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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.
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Through study completion, an average of 24 months
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Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE
Time Frame: Through study completion, an average of 24 months
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Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE at visit 2.
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Through study completion, an average of 24 months
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Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population
Time Frame: Through study completion, an average of 24 months
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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.
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Through study completion, an average of 24 months
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Percentage of failure rate for stiffness and steatosis measurements within TE examination
Time Frame: Through study completion, an average of 24 months
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Percentage of failure rate for stiffness and steatosis measurements within TE examination at visit 1 and 2.
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Through study completion, an average of 24 months
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Percentage of patients with procedure related adverse events and serious adverse events
Time Frame: Through study completion, an average of 24 months
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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.
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Through study completion, an average of 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Pere Ginès, MD, Fundacion Clinic per a la Recerca Biomédica
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2018
Primary Completion (ANTICIPATED)
December 1, 2023
Study Completion (ANTICIPATED)
December 1, 2023
Study Registration Dates
First Submitted
November 14, 2018
First Submitted That Met QC Criteria
December 28, 2018
First Posted (ACTUAL)
December 31, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 16, 2022
Last Update Submitted That Met QC Criteria
September 15, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LiverScreen
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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