Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD
TRAFIC
1 other identifier
interventional
1,045
1 country
20
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2020
CompletedFirst Posted
Study publicly available on registry
December 23, 2020
CompletedStudy Start
First participant enrolled
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 7, 2028
November 18, 2025
November 1, 2025
6.5 years
December 11, 2020
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 months
Secondary Outcomes (5)
Sensitivity for advanced fibrosis
2 months
Parameters influencing the diagnostic accuracy of FIB4-FS and eLIFT-FMVCTE algorithms
2 months
Rate of patients correctly classified for advanced liver fibrosis as a function of the prevalence of advanced fibrosis
2 months
Effect of the choice of the Fibroscan probe on the diagnostic accuracy of FIB4-FS and eLIFT-FMVCTE algorithms
2 months
To validate new biomarkers in a large independent NAFLD population
2 months
Study Arms (1)
Single ARM
OTHEROnly one arm
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)
- Hepatocellular carcinoma
- Inability to safely undergo liver biopsy
- Pregnant, breastfeeding or parturient woman
- Person restricted by judicial or administrative decision
- Person under psychiatric care under restraint
- Person subject to a legal protection measure
- Person unable to express consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University Hospital of Angers
Angers, France
University Hospital of Besançon
Besançon, France
Avicenne Hospital (Greater Paris University Hospitals)
Bobigny, France
University Hospital of Dijon
Dijon, France
Departemental Hospital Center of Vendée
La Roche-sur-Yon, France
University Hospital of Grenoble
La Tronche, France
University Hospital of Lille
Lille, France
University Hospital of Limoges
Limoges, France
Edouard Herriot Hospital
Lyon, France
La Croix Rousse Hospital
Lyon, France
Saint Joseph Hospital
Marseille, France
University Hospital of Montpellier
Montpellier, France
University Hospital of Nantes
Nantes, France
Cochin Hospital
Paris, France
La Pitié Salpétrière Hospital (Greater Paris University Hospitals)
Paris, France
Saint-Antoine Hospital (Greater Paris University Hospitals)
Paris, France
University Hospital of Bordeaux
Pessac, France
University Hospital of Rennes
Rennes, France
University Hospital of Tours
Tours, France
University Hospital of Nancy
Vandœuvre-lès-Nancy, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2020
First Posted
December 23, 2020
Study Start
April 7, 2022
Primary Completion (Estimated)
October 7, 2028
Study Completion (Estimated)
December 7, 2028
Last Updated
November 18, 2025
Record last verified: 2025-11