NAFLDTRAFICNCT04681573
Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD
A study testing blood tests in people with NAFLD, run by University Hospital, Angers at 20 sites in France.
Trial summary
NAFLD, closely linked to overweight and insulin resistance, has reached 25% prevalence worldwide. Advanced liver fibrosis(ALF) must be accurately diagnosed in NAFLD because it defines a subgroup of patients with impaired prognosis, and these patients need a specific management to prevent the occurrence of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NAFLD
- What is being tested?
- blood tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,045 participants
- Where
- 20 sitesFrance
- Study dates
- 7 Apr 2022to 7 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of NAFLD as defined by :
- The presence of liver steatosis as assessed by ultrasonography (bright liver) or magnetic resonance imaging/spectroscopy (fat fraction >5.6%) or Controlled Attenuation Parameter (≥248 dB/m)
- The absence of steatosis-inducing drugs (systemic corticosteroids, methotrexate, amiodarone, tamoxifen)
- The absence of excessive alcohol consumption (<210 g/week in men or <140 g/week in women)
- The absence of other causes of chronic liver disease (chronic viral hepatitis B or C, hemochromatosis, auto-immune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease alpha-1-antitrypsin deficiency).
- Age ≥18 years and ≤80 years
- Affiliated person or beneficiary of a social security regime
- Written informed consent of the patient who agree to comply with the study protocol.
Who cannot join
- Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)
- Hepatocellular carcinoma
- Inability to safely undergo liver biopsy
- Participation in other intervention study with drug protocol treatment in progress at the time of inclusion or within one month prior to inclusion in the study.
- Pregnant, breastfeeding or parturient woman
- Person restricted by judicial or administrative decision
Show all 9Show fewer
- Person under psychiatric care under restraint
- Person subject to a legal protection measure
- Person unable to express consent
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 12 recruiting
- Recruiting
University Hospital of Angers
Angers
Jerome Boursier
- Not yet recruiting
University Hospital of Besançon
Besançon
Tierry Thevenot, +333 81 66 84 21, tthevenot@chu-besancon.fr
- Not yet recruiting
Avicenne Hospital (Greater Paris University Hospitals)
Bobigny
Pierre Nahon
- Recruiting
University Hospital of Dijon
Dijon
Marianne Latournerie
- Recruiting
Departemental Hospital Center of Vendée
La Roche-sur-Yon
Matthieu Schnee
- Active, not recruiting
University Hospital of Grenoble
La Tronche
- Active, not recruiting
University Hospital of Lille
Lille
- Active, not recruiting
University Hospital of Limoges
Limoges
- Not yet recruiting
Edouard Herriot Hospital
Lyon
Jérôme Dumortier, +334 72 11 01 46, jerome.dumortier@chu-lyon.fr
- Recruiting
La Croix Rousse Hospital
Lyon
Maximo Levrero
- Not yet recruiting
Saint Joseph Hospital
Marseille
Marc Bourliere, +334 91 80 82 35, mbourliere@hopital-saint-joseph.fr
- Recruiting
University Hospital of Montpellier
Montpellier
Stéphanie Faure
- Active, not recruiting
University Hospital of Nantes
Nantes
- Not yet recruiting
Cochin Hospital
Paris
Lucia Parlati, +331 58 41 29 88, lucia.parlati@aphp.fr
- Not yet recruiting
La Pitié Salpétrière Hospital (Greater Paris University Hospitals)
Paris
Vlad Ratziu
- Active, not recruiting
Saint-Antoine Hospital (Greater Paris University Hospitals)
Paris
- Active, not recruiting
University Hospital of Bordeaux
Pessac
- Active, not recruiting
University Hospital of Rennes
Rennes
- Active, not recruiting
University Hospital of Tours
Tours
- Not yet recruiting
University Hospital of Nancy
Vandœuvre-lès-Nancy
Jean-Pierre Bronowicki, +333 83 15 33 54, jp.bronoiwicki@chru-nancy.fr
About this study
NAFLD, closely linked to overweight and insulin resistance, has reached 25% prevalence worldwide. Advanced liver fibrosis(ALF) must be accurately diagnosed in NAFLD because it defines a subgroup of patients with impaired prognosis, and these patients need a specific management to prevent the occurrence of liver-related complication. Relatively few NAFLD patients develop ALF and it is a challenge for physicians to identify them.
Liver biopsy is the reference for liver fibrosis evaluation but this invasive procedure cannot be first-line used in NAFLD. Non-invasive diagnosis of liver fibrosis is now available, especially liver stiffness measurement (LSM) with Fibroscan and blood fibrosis tests. However, Fibroscan is a costly device available only in few specialized centres with thus poor accessibility in face of the large NAFLD population. Blood fibrosis tests can be performed by every physician and are distinguished as "complex" or "simple". Because they include specialized biomarkers, complex blood fibrosis tests are accurate for the diagnosis of ALF but they are quite expensive and not reimbursed, with therefore limited use in clinical practice. Simple blood fibrosis tests have the advantage to include cheap and easy-to-obtain biomarkers with simple calculation thanks to free websites or smartphone applications. Simple blood fibrosis tests are globally less accurate than complex blood fibrosis tests or Fibroscan but, used with a high-sensitivity cut-off, they have the high interest of being able to accurately rule out advanced fibrosis in a significant proportion of NAFLD patients.
Read more
Recently, two sequential diagnostic procedures have been developed for the diagnosis of ALF with the idea to combine the advantages of the different kind of fibrosis tests: the FIB4-Fibroscan (FIB4-FS) and the eLIFT-FibroMeterVCTE (eLIFT-FMVCTE) algorithms. These algorithms include as first-line procedure a simple blood fibrosis test (FIB4 or eLIFT) which identifies the patients who require a further second-line evaluation with a more accurate non-invasive test (Fibroscan or FibroMeterVCTE). Liver biopsy is finally used as third-line procedure in patients for whom the diagnosis remains undetermined. Such algorithms have the advantage to limit the use of complex fibrosis tests only to a subset of at risk-patients.
The TRAFIC study compare two strategies for the diagnosis of ALF in NAFLD patients: the FIB4-Fibroscan algorithm and the eLIFT-FibroMeterVCTE algorithm
Read the detailed description
FIB4-FS and the eLIFT-FMVCTE were previosuly directly compared in a database of biopsy-proven NAFLD patients. These two algorithms showed a very good >80% diagnostic accuracy for advanced fibrosis and a very low <15% rate of liver biopsy requirement. The eLIFT-FMVCTE had a significantly higher diagnostic accuracy (84.6% vs 80.6%, p=0.15), was more specific, and provided higher negative and positive predictive value and higher non-invasive diagnostic accuracy. Finally, these preliminary results suggested the eLIFT-FMVCTE was most suitable for clinical practice than the FIB4-FS. However, because almost all these patients from this preliminary comparative study came from the population where the eLIFT-FMVCTE was developed with thus an optimism bias, the results from this direct comparison require further validation.
Therefore, FIB4-FS and the eLIFT-FMVCTE algorithms must now be evaluated and compared in an independent population of NAFLD patients to determine which strategy is the best one for clinical practice.
- Conditions
- NAFLD
- Being tested
- blood tests
- Keywords
- diagnosis, NAFLD, AdvanCed Liver Fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testsDiagnostic test
Also called liver biopsy if required, elastography, biobank
Single arm : all NAFLD patients evaluating the FIB4-FS and the eLIFT-FMVCTE with two patient groups considered at inclusion:
Low-risk group (neither metabolic syndrome nor AST ≥35 UI/l): Liver biopsy won't be mandatory in this group because of the very low risk of advanced fibrosis (4%). These patients will be considered as having no-mild F0-2 liver fibrosis and the study visit will be scheduled for clinical data recording, blood sampling, and LSM with Fibroscan. Liver biopsy could still be performed in the low-risk group if the investigator deems it is required for the clinical management of the patient.
At-risk group (presence of a metabolic syndrome and/or AST ≥35 UI/l): Because of the increased prevalence of significant liver lesions in this group, the patients will have a liver biopsy with clinical data recording, blood sampling, and Fibroscan the same day.
| Study group | Role | What they receive |
|---|---|---|
| Single ARM | Other | Only one arm Receives: Diagnostic Test: blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients correctly classified for advanced liver fibrosis
Rate of patients correctly classified for advanced liver fibrosis, with comparison between the FIB4-FS and eLIFT-FMVCTE algorithms
Measured: 2 months
Secondary outcomes (5)
Sensitivity for advanced fibrosis
Sensitivity for advanced fibrosis, with comparison between the FIB4-FS and eLIFT-FMVCTE algorithms
Measured: 2 months
Parameters influencing the diagnostic accuracy of FIB4-FS and eLIFT-FMVCTE algorithms
Parameters independently associated by multivariate analysis with the rate of patients correctly classified for advanced liver fibrosis
Measured: 2 months
Rate of patients correctly classified for advanced liver fibrosis as a function of the prevalence of advanced fibrosis
Rate of patients correctly classified for advanced liver fibrosis in samples generated by resampling methods with different prevalence of advanced fibrosis (5%, 10%, 15%, 20% and 25%), with comparison between FIB4-FS and eLIFT-FMVCTE algorithms
Measured: 2 months
Effect of the choice of the Fibroscan probe on the diagnostic accuracy of FIB4-FS and eLIFT-FMVCTE algorithms
Rate of patients correctly classified for advanced fibrosis by the algorithms calculated with either LSMAUTO results (i.e., LSM results obtained with the probe, M or XL, which is automatically detected and recommended by the Fibroscan device), or only LSMM results (i.e., LSM results obtained with the M probe), or only LSMXL results (i.e., LSM results obtained with the XL probe).
Measured: 2 months
To validate new biomarkers in a large independent NAFLD population
AUROC for advanced fibrosis, with comparison between the new biomarkers and existing fibrosis tests
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start7 Apr 2022
- Primary completion7 Oct 2028 (estimated)
- Study completion7 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm study including patients with NAFLD
- Masking
- None (open label)
- Enrolment
- 1,045 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681573
- Sponsor's protocol ID
- 2020-A01920-39
- Acronym
- TRAFIC
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD
- ClinicalTrials.gov ID
- NCT04681573
- Acronym / sponsor ID
- TRAFIC / 2020-A01920-39
- Conditions
- NAFLD
- Keywords
- diagnosis, NAFLD, AdvanCed Liver Fibrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,045 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 7 Oct 2028 (estimated)
- Study completion
- 7 Dec 2028 (estimated)
- First posted
- 23 Dec 2020 (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.
NAFLD, closely linked to overweight and insulin resistance, has reached 25% prevalence worldwide. Advanced liver fibrosis(ALF) must be accurately diagnosed in NAFLD because it defines a subgroup of patients with impaired prognosis, and these patients need a specific management to prevent the occurrence of liver-related complication. Relatively few NAFLD patients develop ALF and it is a challenge for physicians to identify them.
Liver biopsy is the reference for liver fibrosis evaluation but this invasive procedure cannot be first-line used in NAFLD. Non-invasive diagnosis of liver fibrosis is now available, especially liver stiffness measurement (LSM) with Fibroscan and blood fibrosis tests. However, Fibroscan is a costly device available only in few specialized centres with thus poor accessibility in face of the large NAFLD population. Blood fibrosis tests can be performed by every physician and are distinguished as "complex" or "simple". Because they include specialized biomarkers, complex blood fibrosis tests are accurate for the diagnosis of ALF but they are quite expensive and not reimbursed, with therefore limited use in clinical practice. Simple blood fibrosis tests have the advantage to include cheap and easy-to-obtain biomarkers with simple calculation thanks to free websites or smartphone applications. Simple blood fibrosis tests are globally less accurate than complex blood fibrosis tests or Fibroscan but, used with a high-sensitivity cut-off, they have the high interest of being able to accurately rule out advanced fibrosis in a significant proportion of NAFLD patients.
Recently, two sequential diagnostic procedures have been developed for the diagnosis of ALF with the idea to combine the advantages of the different kind of fibrosis tests: the FIB4-Fibroscan (FIB4-FS) and the eLIFT-FibroMeterVCTE (eLIFT-FMVCTE) algorithms. These algorithms include as first-line procedure a simple blood fibrosis test (FIB4 or eLIFT) which identifies the patients who require a further second-line evaluation with a more accurate non-invasive test (Fibroscan or FibroMeterVCTE). Liver biopsy is finally used as third-line procedure in patients for whom the diagnosis remains undetermined. Such algorithms have the advantage to limit the use of complex fibrosis tests only to a subset of at risk-patients.
The TRAFIC study compare two strategies for the diagnosis of ALF in NAFLD patients: the FIB4-Fibroscan algorithm and the eLIFT-FibroMeterVCTE algorithm
Detailed description
FIB4-FS and the eLIFT-FMVCTE were previosuly directly compared in a database of biopsy-proven NAFLD patients. These two algorithms showed a very good >80% diagnostic accuracy for advanced fibrosis and a very low <15% rate of liver biopsy requirement. The eLIFT-FMVCTE had a significantly higher diagnostic accuracy (84.6% vs 80.6%, p=0.15), was more specific, and provided higher negative and positive predictive value and higher non-invasive diagnostic accuracy. Finally, these preliminary results suggested the eLIFT-FMVCTE was most suitable for clinical practice than the FIB4-FS. However, because almost all these patients from this preliminary comparative study came from the population where the eLIFT-FMVCTE was developed with thus an optimism bias, the results from this direct comparison require further validation.
Therefore, FIB4-FS and the eLIFT-FMVCTE algorithms must now be evaluated and compared in an independent population of NAFLD patients to determine which strategy is the best one for clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm study including patients with NAFLD
| Arm | Type | Receives |
|---|---|---|
| Single ARM | Other | Diagnostic Test: blood testsOnly one arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Presence of NAFLD as defined by :
- Age ≥18 years and ≤80 years
- Affiliated person or beneficiary of a social security regime
- Written informed consent of the patient who agree to comply with the study protocol.
Key exclusion criteria (9 listed)
- Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)
- Hepatocellular carcinoma
- Inability to safely undergo liver biopsy
- Participation in other intervention study with drug protocol treatment in progress at the time of inclusion or within one month prior to inclusion in the study.
- Pregnant, breastfeeding or parturient woman
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 |
|---|---|---|
| blood testsAlso: liver biopsy if required, elastography, biobankSingle arm : all NAFLD patients evaluating the FIB4-FS and the eLIFT-FMVCTE with two patient groups considered at inclusion: Low-risk group (neither metabolic syndrome nor AST ≥35 UI/l): Liver biopsy won't be mandatory in this group because of the very low risk of advanced fibrosis (4%). These patients will be considered as having no-mild F0-2 liver fibrosis and the study visit will be scheduled for clinical data recording, blood sampling, and LSM with Fibroscan. Liver biopsy could still be performed in the low-risk group if the investigator deems it is required for the clinical management of the patient. At-risk group (presence of a metabolic syndrome and/or AST ≥35 UI/l): Because of the increased prevalence of significant liver lesions in this group, the patients will have a liver biopsy with clinical data recording, blood sampling, and Fibroscan the same day. | Diagnostic test | Single ARM |
Primary outcome
Rate of patients correctly classified for advanced liver fibrosis
Time frame: 2 months
Rate of patients correctly classified for advanced liver fibrosis, with comparison between the FIB4-FS and eLIFT-FMVCTE algorithms
5 secondary outcomes
Sensitivity for advanced fibrosis
Time frame: 2 months
Parameters influencing the diagnostic accuracy of FIB4-FS and eLIFT-FMVCTE algorithms
Time frame: 2 months
Rate of patients correctly classified for advanced liver fibrosis as a function of the prevalence of advanced fibrosis
Time frame: 2 months
Effect of the choice of the Fibroscan probe on the diagnostic accuracy of FIB4-FS and eLIFT-FMVCTE algorithms
Time frame: 2 months
To validate new biomarkers in a large independent NAFLD population
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood tests in people with NAFLD, run by University Hospital, Angers at 20 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Boursier, MD-PHD (+33241353410, jeboursier@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients correctly classified for advanced liver fibrosis (time frame: 2 months). 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 18 Nov 2025.