Population-based Study in Screening for Liver Fibrosis

Liver Diseases Clinical Trial

— LiverScreen  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03789825
• Other study ID #: LiverScreen
• Status: Enrolling by invitation
• Start date: May 1, 2018
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Diseases

Locations

Country	Name	City	State
Croatia	Dubrava Hospital	Zagreb
Croatia	Poliklinika Croatia	Zagreb
Denmark	Odense University Hospital	Odense
France	Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers	Gennevilliers
France	Centre de Recherche Clinique - CRC	Paris
France	Hospital Avicenne	Paris
France	Hospital Beaujon	Paris
Germany	Homburg Hospital	Homburg
Germany	Mainz Hospital	Mainz
Germany	MVZ Dres.Schneider Kaiserslautern	Rodenbach
Netherlands	Medical Center Rotterdam	Rotterdam
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	CAP Adrià	Barcelona
Spain	CAP Barceloneta	Barcelona
Spain	CAP Bordeta-Magòria	Barcelona
Spain	CAP Ciutat Meridiana	Barcelona
Spain	CAP La Marina	Barcelona
Spain	CAP Numància	Barcelona
Spain	CAP Río de Janeiro	Barcelona
Spain	CAP Sant Rafael	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universirati Vall d'Hebrón	Barcelona
Spain	SEAT	Martorell	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 Perpètua De Mogoda	Barcelona
United Kingdom	Oak Lodge Medical Centre	Edgware
United Kingdom	Royal Free Hospital	London
United Kingdom	St Andrews Medical Practice	London
United Kingdom	Nottingham University Hospital	Nottingham
United Kingdom	King's Mill Hospital	Sutton In Ashfield

Sponsors (1)

Lead Sponsor	Collaborator
Judit Pich Martínez

Countries where clinical trial is conducted

Croatia,  Denmark,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of subjects with Liver stiffness measurement by Transient Elastography >=8 Kpa at any visit	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	% 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	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
Secondary	Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores	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
Secondary	Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy	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
Secondary	% of subjects with CAP =250 dB/m2	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
Secondary	Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores	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
Secondary	Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores and liver biopsy	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
Secondary	Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound	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
Secondary	Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE	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
Secondary	Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population	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
Secondary	Percentage of failure rate for stiffness and steatosis measurements within TE examination	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
Secondary	Percentage of patients with procedure related adverse events and serious adverse events	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