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

      • Zagreb, Croatia, 10000
        • Dubrava Hospital
      • Zagreb, Croatia, 1000
        • Poliklinika Croatia
      • Odense, Denmark
        • Odense University Hospital
      • Gennevilliers, France, 92230
        • Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers
      • Paris, France
        • Centre de Recherche Clinique - CRC
      • Paris, France
        • Hospital AVICENNE
      • Paris, France
        • Hospital Beaujon
      • Homburg, Germany
        • Homburg Hospital
      • Mainz, Germany
        • Mainz Hospital
      • Rodenbach, Germany
        • MVZ Dres.Schneider Kaiserslautern
      • Rotterdam, Netherlands
        • Medical Center Rotterdam
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08003
        • CAP Barceloneta
      • Barcelona, Spain, 08014
        • CAP Bordeta-Magòria
      • Barcelona, Spain, 08016
        • CAP Río de Janeiro
      • Barcelona, Spain, 08033
        • CAP Ciutat Meridiana
      • Barcelona, Spain, 08035
        • CAP Sant Rafael
      • Barcelona, Spain, 08035
        • Hospital Universirati Vall d'Hebrón
      • Barcelona, Spain
        • CAP Adrià
      • Barcelona, Spain
        • CAP La Marina
      • Barcelona, Spain
        • CAP Numància
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Germans Trias i Pujol
      • Martorell, Barcelona, Spain, 08760
        • SEAT
      • Mataró, Barcelona, Spain
        • CAP II El Maresme
      • Santa Coloma De Gramenet, Barcelona, Spain
        • CAP II Santa Coloma de Gramanet
      • Santa Perpètua De Mogoda, Barcelona, Spain
        • CAP La Florida
      • Edgware, United Kingdom, HA8 0AP
        • Oak Lodge Medical Centre
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom
        • St Andrews Medical Practice
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospital
      • Sutton In Ashfield, United Kingdom, NG17 4JL
        • King's Mill Hospital

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
% of subjects with Liver stiffness measurement by Transient Elastography >=8 Kpa at any visit
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: 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 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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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