Population-based Study in Screening for Liver Fibrosis

NCT ID: NCT03789825

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-19

Study Completion Date

2025-01-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Judit Pich Martínez

OTHER

Sponsor Role lead

Responsible Party

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Judit Pich Martínez

Clinical Research Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pere Ginès, MD

Role: STUDY_CHAIR

Fundacion Clinic per a la Recerca Biomédica

Locations

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Dubrava Hospital

Zagreb, , Croatia

Site Status

Poliklinika Croatia

Zagreb, , Croatia

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers

Gennevilliers, , France

Site Status

Centre de Recherche Clinique - CRC

Paris, , France

Site Status

Hospital Avicenne

Paris, , France

Site Status

Hospital Beaujon

Paris, , France

Site Status

Homburg Hospital

Homburg, , Germany

Site Status

Altstadtpraxis

Mainz, , Germany

Site Status

Mainz Hospital

Mainz, , Germany

Site Status

Praxis Mombach

Mainz, , Germany

Site Status

MVZ Dres.Schneider Kaiserslautern

Rodenbach, , Germany

Site Status

Medicina Di gruppo di montagnana

Padua, , Italy

Site Status

Vigonza Medica

Padua, , Italy

Site Status

Medical Center Rotterdam

Rotterdam, , Netherlands

Site Status

F. D. Roosevelt Univ. Hospital

Banská Bystrica, , Slovakia

Site Status

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

SEAT

Martorell, Barcelona, Spain

Site Status

CAP II El Maresme

Mataró, Barcelona, Spain

Site Status

CAP II Santa Coloma de Gramanet

Santa Coloma de Gramenet, Barcelona, Spain

Site Status

CAP La Florida

Santa Perpètua de Mogoda, Barcelona, Spain

Site Status

CAP Barceloneta

Barcelona, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

CAP Bordeta-Magòria

Barcelona, , Spain

Site Status

CAP Río de Janeiro

Barcelona, , Spain

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CAP Ciutat Meridiana

Barcelona, , Spain

Site Status

CAP Sant Rafael

Barcelona, , Spain

Site Status

Hospital Universirati Vall d'Hebrón

Barcelona, , Spain

Site Status

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status

CAP Adrià

Barcelona, , Spain

Site Status

CAP Besos

Barcelona, , Spain

Site Status

CAP La Marina

Barcelona, , Spain

Site Status

CAP Numància

Barcelona, , Spain

Site Status

CAP Vila de Gracia

Barcelona, , Spain

Site Status

CAP Vila Olimpica

Barcelona, , Spain

Site Status

Hospital Gregorio Marañon

Madrid, , Spain

Site Status

CAP La Llantia

Mataró, , Spain

Site Status

Oak Lodge Medical Centre

Edgware, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

James Wigg

London, , United Kingdom

Site Status

Mild May

London, , United Kingdom

Site Status

Oakleigh park

London, , United Kingdom

Site Status

St Andrews Medical Practice

London, , United Kingdom

Site Status

Nottingham University Hospital

Nottingham, , United Kingdom

Site Status

King's Mill Hospital

Sutton in Ashfield, , United Kingdom

Site Status

Countries

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Croatia Denmark France Germany Italy Netherlands Slovakia Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35854275 (View on PubMed)

Other Identifiers

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LiverScreen

Identifier Type: -

Identifier Source: org_study_id

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