Clinical trial NCT03789825: Population-based Study in Screening for Liver Fibrosis
Official title: Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 30000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population above 40 years

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

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.

Eligibility 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)

Primary outcomes:
measure: % of subjects with Liver stiffness measurement by Transient Elastography >=8 kPa at any visit
timeFrame: Through study completion, an average of 24 months
Secondary outcomes:
measure: % 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
timeFrame: Through study completion, an average of 24 months
measure: Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores
timeFrame: Through study completion, an average of 24 months
measure: Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy
timeFrame: Through study completion, an average of 24 months
measure: % of subjects with CAP ≥250 dB/m
timeFrame: Through study completion, an average of 24 months
measure: Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores
timeFrame: Through study completion, an average of 24 months
measure: Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores and liver biopsy
timeFrame: Through study completion, an average of 24 months
measure: Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound
timeFrame: Through study completion, an average of 24 months
measure: Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE
timeFrame: Through study completion, an average of 24 months
measure: Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population
timeFrame: Through study completion, an average of 24 months
measure: Percentage of failure rate for stiffness and steatosis measurements within TE examination
timeFrame: Through study completion, an average of 24 months
measure: Percentage of patients with procedure related adverse events and serious adverse events
timeFrame: Through study completion, an average of 24 months
measure: Percentage of patients with changes in lifestyle habits
timeFrame: Through study completion, an average of 24 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Dubrava Hospital
city: Zagreb
country: Croatia
facility: Poliklinika Croatia
city: Odense
country: Denmark
facility: Odense University Hospital
city: Gennevilliers
country: France
facility: Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers
city: Paris
country: France
facility: Centre de Recherche Clinique - CRC
city: Paris
country: France
facility: Hospital Avicenne
city: Paris
country: France
facility: Hospital Beaujon
city: Homburg
country: Germany
facility: Homburg Hospital
city: Mainz
country: Germany
facility: Altstadtpraxis
city: Mainz
country: Germany
facility: Mainz Hospital
city: Mainz
country: Germany
facility: Praxis Mombach
city: Rodenbach
country: Germany
facility: MVZ Dres.Schneider Kaiserslautern
city: Padova
country: Italy
facility: Medicina Di gruppo di montagnana
city: Padova
country: Italy
facility: Vigonza Medica
city: Rotterdam
country: Netherlands
facility: Medical Center Rotterdam
city: Banská Bystrica
country: Slovakia
facility: F. D. Roosevelt Univ. Hospital
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Martorell
country: Spain
facility: SEAT
state: Barcelona
city: Mataró
country: Spain
facility: CAP II El Maresme
state: Barcelona
city: Santa Coloma De Gramenet
country: Spain
facility: CAP II Santa Coloma de Gramanet
state: Barcelona
city: Santa Perpètua De Mogoda
country: Spain
facility: CAP La Florida
state: Barcelona
city: Barcelona
country: Spain
facility: CAP Barceloneta
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: CAP Bordeta-Magòria
city: Barcelona
country: Spain
facility: CAP Río de Janeiro
city: Barcelona
country: Spain
facility: CAP Ciutat Meridiana
city: Barcelona
country: Spain
facility: CAP Sant Rafael
city: Barcelona
country: Spain
facility: Hospital Universirati Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: CAP Adrià
city: Barcelona
country: Spain
facility: CAP Besos
city: Barcelona
country: Spain
facility: CAP La Marina
city: Barcelona
country: Spain
facility: CAP Numància
city: Barcelona
country: Spain
facility: CAP Vila de Gracia
city: Barcelona
country: Spain
facility: CAP Vila Olimpica
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Mataró
country: Spain
facility: CAP La Llantia
city: Edgware
country: United Kingdom
facility: Oak Lodge Medical Centre
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: James Wigg
city: London
country: United Kingdom
facility: Mild May
city: London
country: United Kingdom
facility: Oakleigh park
city: London
country: United Kingdom
facility: St Andrews Medical Practice
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Sutton In Ashfield
country: United Kingdom
facility: King's Mill Hospital
Study officials:
affiliation: Fundacion Clinic per a la Recerca Biomédica
name: Pere Ginès, MD
role: STUDY_CHAIR
References:
citation: Graupera I, Thiele M, Ma AT, Serra-Burriel M, Pich J, Fabrellas N, Caballeria L, de Knegt RJ, Grgurevic I, Reichert M, Roulot D, Schattenberg JM, Pericas JM, Angeli P, Tsochatzis EA, Guha IN, Garcia-Retortillo M, Morillas RM, Hernandez R, Hoyo J, Fuentes M, Madir A, Juanola A, Soria A, Juan M, Carol M, Diaz A, Detlefsen S, Toran P, Pera G, Fournier C, Llorca A, Newsome PN, Manns M, de Koning HJ, Serra-Burriel F, Cucchietti F, Arslanow A, Korenjak M, van Kleef L, Falco JL, Kamath PS, Karlsen TH, Castera L, Lammert F, Krag A, Gines P; LiverScreen Consortium investigators. LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries. BMC Public Health. 2022 Jul 19;22(1):1385. doi: 10.1186/s12889-022-13724-6.