ScreeningSCREANITNCT05880173
SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population
A study testing FIB4 in people with Screening and Advanced Liver Fibrosis, run by University Hospital, Angers at 6 sites in France.
Trial summary
The main objective of the study is to evaluate the pertinence of initiating screening for advanced hepatic fibrosis after a FIB4 result > 2.67 automatically calculated in the local laboratory and followed by a specialized hepatic evaluation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Screening, Advanced Liver Fibrosis
- What is being tested?
- FIB4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 6 sitesFrance
- Study dates
- 20 Oct 2023to 5 Mar 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Blood sample taken at a medical testing laboratory selected for the study.
- Biology without high risk of false positive result for FIB4 (AST and ALT ≤ 300 IU/l ; Platelets ≥ 50 G/l and < 500 G/l.)
- FIB4 > 2.67 after automatic calculation in the medical laboratory less than 3 months old
- Signature of informed consent to participate in the study
Who cannot join
- Ongoing specialized follow-up for a chronic liver disease
- Difficulty understanding the French language
- Pregnant women, breastfeeding or parturient women
- Persons suspended from liberty by judicial or administrative decision
- Persons under legal protection
- Persons unable to express their consent
- Non affiliation to a social security system
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Chu Angers
Angers, 49000
Chu Bordeaux
Angers, 49000
Chu Grenoble Alpes
Grenoble
Centre Hospitalier de Lens
Lens
Hopital Saint Joseph
Marseille
Chu Nancy
Nancy
About this study
The main objective of the study is to evaluate the pertinence of initiating screening for advanced hepatic fibrosis after a FIB4 result > 2.67 automatically calculated in the local laboratory and followed by a specialized hepatic evaluation.
Read the detailed description
Chronic liver diseases are insidious diseases characterized by inflammation of the liver parenchyma responsible for a progressive accumulation of fibrosis until cirrhosis and hepatocellular carcinoma (HCC). Cirrhosis and HCC are respectively the 11th and 16th most frequent causes of death in the world, and are responsible for 2 million deaths each year. Cirrhosis and HCC are most often diagnosed too late with a median survival of 18-24 months.
The degree of hepatic fibrosis is the main predictive factor of the risk of hepatic complications (decompensation of cirrhosis, HCC) in chronic liver diseases.
Hepatic fibrosis is described in 5 stages from F0 (no fibrosis) to F4 (cirrhosis). It is well accepted that patients with advanced hepatic fibrosis (F3 and F4) are at the highest risk of developing complications of cirrhosis and/or HCC. It is therefore necessary to identify these patients in order to offer them specialized management.
Tests have been developed over the last two decades for the non-invasive diagnosis of liver fibrosis, essentially the fibrosis blood test (FIB4) and liver elastometry devices (fibroScan). The FIB4 is a simple blood test that is easy to calculate from the usual inexpensive blood parameters (ASAT, ALAT, platelets). The recommendations of French, European and American scientific societies are unanimous and recommend targeted screening for liver fibrosis in patients with hepatic risk factors using FIB4 as a first line test.
To facilitate screening by general practitioners, several French consortia of medical analysis laboratories have set up routine calculation of FIB4 on all biological tests, including platelets, AST and ALT, without regard to the patient's risk factors for liver disease. This approach is not in concordance with the recommendations of the scientific societies (targeted screening in patients with hepatic risk factors) and needs to be evaluated.
The purpose of this study is to evaluate if the procedure for diagnosing hepatic fibrosis implemented by some local laboratories and based on an automated calculation of FIB4 is pertinent.
- Conditions
- Screening, Advanced Liver Fibrosis
- Being tested
- FIB4
- Keywords
- Screening, advanced liver fibrosis, non-invasive tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIB4Diagnostic test
Diagnostic procedure :
FIB4 blood tests in medical analysis laboratories. If FIB4 positive, Non invasive spacialized evaluation (transient elastography and FibroMeter) by a specialist and if necessery liver biopsy, endoscopy and/or echography
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic FIB4 | Other | Only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference Receives: Diagnostic Test: FIB4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of advanced hepatic fibrosis.
The endpoint for this objective will be the diagnosis of advanced liver fibrosis is a stage of F3-4 fibrosis on liver biopsy (NASH-CRN classification), in patients with a FIB4> 2.67 and a FibroScan result ≥ 8 kPa.
Measured: 3 months maximum
Secondary outcomes (6)
Determine the rate of patients requiring second-line evaluation by elastometry
The endpoint for this objective will be the rate of patients with FIB4 >2.67.
Measured: 3 months maximum
Determine the rate of patients requiring management by a liver disease specialist.
The endpoint for this objective will be the rate of patients with a FIB4 >2.67 and then a FibroScan ≥8.0 kPa.
Measured: 3 months maximum
Determine the average cost spent on a patient diagnosed with advanced liver fibrosis
The endpoint for this objective will be the average direct cost of all procedures performed in the screening procedure.
Measured: 3 months maximum
Determine patient adherence to the screening procedure
The endpoint for this objective will be the rate of patients performing the procedures in accordance with the screening procedure.
Measured: 3 months maximum
Determine risk factors associated with advanced liver fibrosis, and consequently the subgroup of patients for whom screening should be a priority
The endpoint for this objective will be multivariate analysis of risk factors according to the stage of detected liver fibrosis
Measured: 3 months maximum
Determine the rate of patients with a significant liver complication in the population of patients with risk factors
The endpoints for this objective will be the number of diagnosed hepatocellular carcinoma and esophageal/gastric varices with bleeding risk.
Measured: 3 months maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start20 Oct 2023
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScreeningStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880173
- Sponsor's protocol ID
- 49RC22_0086
- Acronym
- SCREANIT
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population
- ClinicalTrials.gov ID
- NCT05880173
- Acronym / sponsor ID
- SCREANIT / 49RC22_0086
- Conditions
- Screening, Advanced Liver Fibrosis
- Keywords
- Screening, advanced liver fibrosis, non-invasive tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 30 May 2023 (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.
The main objective of the study is to evaluate the pertinence of initiating screening for advanced hepatic fibrosis after a FIB4 result > 2.67 automatically calculated in the local laboratory and followed by a specialized hepatic evaluation.
Detailed description
Chronic liver diseases are insidious diseases characterized by inflammation of the liver parenchyma responsible for a progressive accumulation of fibrosis until cirrhosis and hepatocellular carcinoma (HCC). Cirrhosis and HCC are respectively the 11th and 16th most frequent causes of death in the world, and are responsible for 2 million deaths each year. Cirrhosis and HCC are most often diagnosed too late with a median survival of 18-24 months.
The degree of hepatic fibrosis is the main predictive factor of the risk of hepatic complications (decompensation of cirrhosis, HCC) in chronic liver diseases.
Hepatic fibrosis is described in 5 stages from F0 (no fibrosis) to F4 (cirrhosis). It is well accepted that patients with advanced hepatic fibrosis (F3 and F4) are at the highest risk of developing complications of cirrhosis and/or HCC. It is therefore necessary to identify these patients in order to offer them specialized management.
Tests have been developed over the last two decades for the non-invasive diagnosis of liver fibrosis, essentially the fibrosis blood test (FIB4) and liver elastometry devices (fibroScan). The FIB4 is a simple blood test that is easy to calculate from the usual inexpensive blood parameters (ASAT, ALAT, platelets). The recommendations of French, European and American scientific societies are unanimous and recommend targeted screening for liver fibrosis in patients with hepatic risk factors using FIB4 as a first line test.
To facilitate screening by general practitioners, several French consortia of medical analysis laboratories have set up routine calculation of FIB4 on all biological tests, including platelets, AST and ALT, without regard to the patient's risk factors for liver disease. This approach is not in concordance with the recommendations of the scientific societies (targeted screening in patients with hepatic risk factors) and needs to be evaluated.
The purpose of this study is to evaluate if the procedure for diagnosing hepatic fibrosis implemented by some local laboratories and based on an automated calculation of FIB4 is pertinent.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic FIB4 | Other | Diagnostic Test: FIB4Only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 70 years
- Blood sample taken at a medical testing laboratory selected for the study.
- Biology without high risk of false positive result for FIB4 (AST and ALT ≤ 300 IU/l ; Platelets ≥ 50 G/l and < 500 G/l.)
- FIB4 > 2.67 after automatic calculation in the medical laboratory less than 3 months old
- Signature of informed consent to participate in the study
Key exclusion criteria (7 listed)
- Ongoing specialized follow-up for a chronic liver disease
- Difficulty understanding the French language
- Pregnant women, breastfeeding or parturient women
- Persons suspended from liberty by judicial or administrative decision
- Persons under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIB4Diagnostic procedure : FIB4 blood tests in medical analysis laboratories. If FIB4 positive, Non invasive spacialized evaluation (transient elastography and FibroMeter) by a specialist and if necessery liver biopsy, endoscopy and/or echography | Diagnostic test | Diagnostic FIB4 |
Primary outcome
Proportion of advanced hepatic fibrosis.
Time frame: 3 months maximum
The endpoint for this objective will be the diagnosis of advanced liver fibrosis is a stage of F3-4 fibrosis on liver biopsy (NASH-CRN classification), in patients with a FIB4> 2.67 and a FibroScan result ≥ 8 kPa.
6 secondary outcomes
Determine the rate of patients requiring second-line evaluation by elastometry
Time frame: 3 months maximum
Determine the rate of patients requiring management by a liver disease specialist.
Time frame: 3 months maximum
Determine the average cost spent on a patient diagnosed with advanced liver fibrosis
Time frame: 3 months maximum
Determine patient adherence to the screening procedure
Time frame: 3 months maximum
Determine risk factors associated with advanced liver fibrosis, and consequently the subgroup of patients for whom screening should be a priority
Time frame: 3 months maximum
Determine the rate of patients with a significant liver complication in the population of patients with risk factors
Time frame: 3 months maximum
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIB4 in people with Screening and Advanced Liver Fibrosis, run by University Hospital, Angers at 6 sites in France.
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 5 inclusion and 7 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Proportion of advanced hepatic fibrosis. (time frame: 3 months maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.