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LiverScreen: Population-based Study in Screening for Liver Fibrosis

Sponsor
Judit Pich Martínez (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03789825
Collaborator
(none)
20,000
Enrollment
28
Locations
67
Anticipated Duration (Months)
714.3
Patients Per Site
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.
    Actual Study Start Date :
    May 1, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. % of subjects with Liver stiffness measurement by Transient Elastography >=8 Kpa at any visit [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.

    Secondary Outcome Measures

    1. % 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]

      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.

    2. 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 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.

    3. Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy [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.

    4. % of subjects with CAP ≥250 dB/m2 [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

    5. Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores [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.

    6. Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores and liver biopsy [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).

    7. Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound [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.

    8. Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE [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.

    9. Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population [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.

    10. Percentage of failure rate for stiffness and steatosis measurements within TE examination [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.

    11. Percentage of patients with procedure related adverse events and serious adverse events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dubrava Hospital Zagreb Croatia 10000
    2 Poliklinika Croatia Zagreb Croatia 1000
    3 Odense University Hospital Odense Denmark
    4 Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers Gennevilliers France 92230
    5 Hospital Avicenne Paris France
    6 Hospital Beaujon Paris France
    7 Homburg Hospital Homburg Germany
    8 Mainz Hospital Mainz Germany
    9 Medical Center Rotterdam Rotterdam Netherlands
    10 Hospital Germans Trias i Pujol Badalona Barcelona Spain
    11 SEAT Martorell Barcelona Spain 08760
    12 CAP II El Maresme Mataró Barcelona Spain
    13 CAP II Santa Coloma de Gramanet Santa Coloma De Gramenet Barcelona Spain
    14 CAP La Florida Santa Perpètua De Mogoda Barcelona Spain
    15 CAP Barceloneta Barcelona Spain 08003
    16 Hospital del Mar Barcelona Spain 08003
    17 CAP Bordeta-Magòria Barcelona Spain 08014
    18 CAP Río de Janeiro Barcelona Spain 08016
    19 CAP Ciutat Meridiana Barcelona Spain 08033
    20 CAP Sant Rafael Barcelona Spain 08035
    21 Hospital Universirati Vall d'Hebrón Barcelona Spain 08035
    22 Hospital Clínic de Barcelona Barcelona Spain 08036
    23 CAP La Marina Barcelona Spain
    24 CAP Numància Barcelona Spain
    25 Oak Lodge Medical Centre Edgware United Kingdom HA8 0AP
    26 Royal Free Hospital London United Kingdom NW3 2QG
    27 Nottingham University Hospital Nottingham United Kingdom NG5 1PB
    28 King's Mill Hospital Sutton In Ashfield United Kingdom NG17 4JL

    Sponsors and Collaborators

    • Judit Pich Martínez

    Investigators

    • Study Chair: Pere Ginès, MD, Fundacion Clinic per a la Recerca Biomédica

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Judit Pich Martínez, Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica
    ClinicalTrials.gov Identifier:
    NCT03789825
    Other Study ID Numbers:
    • LiverScreen
    First Posted:
    Dec 31, 2018
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases
    Liver Cirrhosis

    Study Results

    No Results Posted as of Jun 15, 2022