SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Angers
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
FIB4
Diagnostic testDiagnostic 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
Treatment groups
502 Participants
are divided into 1 treatment groupGroup A: Diagnostic FIB4Other 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months maximumSecondary outcomes
1
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.
Time frame
3 months maximum2
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.
Time frame
3 months maximum3
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.
Time frame
3 months maximum4
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.
Time frame
3 months maximumSponsors and contacts
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Source ClinicalTrials.gov