Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Population-based Study in Screening for Liver Fibrosis (LiverScreen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789825
Recruitment Status : Enrolling by invitation
First Posted : December 31, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Judit Pich Martínez, Fundacion Clinic per a la Recerca Biomédica

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

Condition or disease
Liver Diseases

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.

Layout table for study information
Study Type : Observational
Estimated 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 ≥ 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 [ 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.

  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/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

  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.


Biospecimen Retention:   Samples With DNA
Plasma and serum specimens will be retained in a repository


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
General population above 40 years
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789825


Locations
Layout table for location information
Denmark
Odense University Hospital
Odense, Denmark
France
Hospital Avicenne
Paris, France
Hospital Beaujon
Paris, France
Netherlands
Medical Center Rotterdam
Rotterdam, Netherlands
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
CAP II El Maresme
Mataró, Barcelona, Spain
CAP II Santa Coloma de Gramanet
Santa Coloma De Gramenet, Barcelona, Spain
CAP La Florida
Santa Perpetua, Barcelona, Spain
CAP Bordeta-Magòria
Barcelona, Spain, 08014
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
CAP La Marina
Barcelona, Spain
CAP Numància
Barcelona, Spain
Sponsors and Collaborators
Judit Pich Martínez

Layout table for additonal information
Responsible Party: Judit Pich Martínez, Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT03789825     History of Changes
Other Study ID Numbers: LiverScreen
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Liver Cirrhosis
Digestive System Diseases