Skip to main content
OpenTrials
Completed

NCT Number: NCT03789825

Population-based Study in Screening for Liver Fibrosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dubrava Hospital, Zagreb, Croatia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. % 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 ≥ 8 kPa at any visit, either with M or XL probe, in general population.

Secondary outcomes

  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

    Time frame: Through study completion, an average of 24 months

    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.

  2. 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.

  3. 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.

  4. % of subjects with CAP ≥250 dB/m

    Time frame: Through study completion, an average of 24 months

    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

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Percentage of patients with changes in lifestyle habits

    Time frame: Through study completion, an average of 24 months

    Percentage of patients with changes in lifestyle habits

Sponsors and collaborators

Lead sponsor

Judit Pich Martínez

Other

Registry information

Official study title

Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.

Acronym: LiverScreen

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Dec 31, 2018
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.