Liver DiseasesLiverScreenNCT03789825
Population-based Study in Screening for Liver Fibrosis
An observational study of Liver Diseases, run by Judit Pich Martínez at 45 sites in 9 countries.
Trial summary
Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- How many people
- 30,000 participants
- Where
- 45 sitesin 9 countries
- Study dates
- 19 Mar 2018to 7 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population above 40 years
Who may be able to join
- Age ≥ 40 years
- Able to give informed consent
Who cannot join
- 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)
Trial locations and contacts
45 sites in 9 countries.
45 sites in 9 countries
Spain21 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona
CAP Barceloneta
Barcelona, 08003
Hospital del Mar
Barcelona, 08003
CAP Bordeta-Magòria
Barcelona, 08014
CAP Río de Janeiro
Barcelona, 08016
CAP Ciutat Meridiana
Barcelona, 08033
CAP Sant Rafael
Barcelona, 08035
Hospital Universirati Vall d'Hebrón
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
CAP Adrià
Barcelona
CAP Besos
Barcelona
CAP La Marina
Barcelona
CAP Numància
Barcelona
CAP Vila de Gracia
Barcelona
CAP Vila Olimpica
Barcelona
Hospital Gregorio Marañon
Madrid
SEAT
Martorell, Barcelona, 08760
CAP II El Maresme
Mataró, Barcelona
CAP La Llantia
Mataró
CAP II Santa Coloma de Gramanet
Santa Coloma de Gramenet, Barcelona
CAP La Florida
Santa Perpètua de Mogoda, Barcelona
United Kingdom8 sites
Oak Lodge Medical Centre
Edgware, HA8 0AP
Royal Free Hospital
London, NW3 2QG
James Wigg
London
Mild May
London
Oakleigh park
London
St Andrews Medical Practice
London
Nottingham University Hospital
Nottingham, NG5 1PB
King's Mill Hospital
Sutton in Ashfield, NG17 4JL
Germany5 sites
Homburg Hospital
Homburg
Altstadtpraxis
Mainz
Mainz Hospital
Mainz
Praxis Mombach
Mainz
MVZ Dres.Schneider Kaiserslautern
Rodenbach
France4 sites
Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers
Gennevilliers, 92230
Centre de Recherche Clinique - CRC
Paris
Hospital Avicenne
Paris
Hospital Beaujon
Paris
About this study
Official title: Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.
Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography
Read the 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.
- Conditions
- Liver Diseases
- Medical subject headings
- Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
% of subjects with Liver stiffness measurement by Transient Elastography >=8 kPa at any visit
Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8 kPa at any visit, either with M or XL probe, in general population.
Measured: Through study completion, an average of 24 months
Secondary outcomes (12)
% 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 ≥ 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.
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
% of subjects with CAP ≥250 dB/m
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
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
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).
Measured: Through study completion, an average of 24 months
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.
Measured: 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
Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE at visit 2.
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
Percentage of patients with changes in lifestyle habits
Percentage of patients with changes in lifestyle habits
Measured: Through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start19 Mar 2018
- Primary completion7 Nov 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Judit Pich Martínez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Judit Pich Martínez, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Pere Ginès, MD, Study chair, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789825
- Sponsor's protocol ID
- LiverScreen
- Acronym
- LiverScreen
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2018
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35854275
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Liver Fibrosis. A Population-based Study in European Countries. The ''LiverScreen'' Project.
- ClinicalTrials.gov ID
- NCT03789825
- Acronym / sponsor ID
- LiverScreen / LiverScreen
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- Judit Pich MartínezUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population above 40 years
Key inclusion criteria (2 listed)
- Age ≥ 40 years
- Able to give informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
% 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.
12 secondary outcomes
% 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
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, fibrosis scores and liver biopsy
Time frame: Through study completion, an average of 24 months
% of subjects with CAP ≥250 dB/m
Time frame: Through study completion, an average of 24 months
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, steatosis scores and liver biopsy
Time frame: Through study completion, an average of 24 months
Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound
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
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
Time frame: Through study completion, an average of 24 months
Percentage of failure rate for stiffness and steatosis measurements within TE examination
Time frame: Through study completion, an average of 24 months
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 changes in lifestyle habits
Time frame: Through study completion, an average of 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 35854275Graupera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pere Ginès, MD study chair
Fundacion Clinic per a la Recerca Biomédica
45 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Judit Pich Martínez at 45 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Spain, United Kingdom, Germany, France, Croatia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of subjects with Liver stiffness measurement by Transient Elastography >=8 kPa at any visit (time frame: Through study completion, an average of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03789825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.