Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
ID06366425

Non-invasive Screening for Chronic Liver Diseases in the General Population A Prospective Study

Led by University Hospital, Montpellier · Updated on 2025-07-10

260

Participants Needed

1

Research Sites

220 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Montpellier

Lead Sponsor

O

On-call medical home (MMG) Clermont-Hérault

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating non-invasive screening methods for chronic liver diseases, particularly focusing on detecting advanced liver fibrosis in the general population aged 40 years and older. The study addresses the increasing prevalence of conditions like non-alcoholic fatty liver disease and hepatocellular carcinoma, aiming to improve liver disease care in primary settings by refining screening approaches. Participants who meet the criteria will first undergo a blood test to calculate the FIB-4 score, which uses age, liver enzyme levels, and platelet count to identify possible advanced fibrosis. If the FIB-4 score is higher than 1.3, participants will be offered a Fibroscan, a non-invasive scan that measures liver stiffness and aids in diagnosing chronic liver disease. This two-step approach is intended to enhance the accuracy of liver fibrosis detection without requiring invasive biopsy. During the study, participants will have assessments at the initial visit and again one month later, including blood tests, Fibroscan scans (if applicable), and questionnaires about alcohol use and medical history. Researchers will evaluate how acceptable the screening methods are to participants and analyze the prevalence of advanced fibrosis and related risk factors. The study collects demographic information and monitors outcomes to better understand liver disease screening in the community over time.

CONDITIONS

Brief Title

Screening for Chronic Liver Diseases in General Population

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 years or older
  • No known liver diseases
  • At least one risk factor for chronic liver disease such as risky alcohol consumption according to the AUDIT questionnaire, metabolic syndrome, diabetes, or risk factors for viral hepatitis B, D, or C
Not Eligible

You will not qualify if you...

  • Fibroscan performed within the last 12 months
  • Inability to provide express oral consent
  • Not affiliated with or not benefiting from a national health insurance scheme
  • Patient protected by law
  • Under guardianship or curatorship
  • Deprived of liberty
  • Pregnant or breastfeeding woman

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for blood test and initial assessment

Diagnostic Evaluation

Duration - Up to 1 month

Participants receive a blood test to calculate the FIB-4 score. If the score is greater than 1.3, participants are offered a non-invasive liver fibrosis assessment by Fibroscan.

1 additional visit (in-person) for Fibroscan if eligible and willing

Long-term Monitoring

Duration - Ongoing after diagnostic evaluations

Participants with risk factors for chronic liver disease are observed to raise awareness and refine screening for chronic liver diseases.

No scheduled visits; follow-up depends on individual clinical care

Trial Site Locations

Total: 1 location

1

CHU de Montpellier

Montpellier, France, 34295

Actively Recruiting

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Research Team

M

Magdalena MESZAROS, MD

C

Corinne ROTROU, CRA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Liver disease knowledge and acceptability of non-invasive liver fibrosis assessment among people who inject drugs in the drug and alcohol setting: The LiveRLife Study.

A D Marshall, M Micallef, A Erratt...

https://pubmed.ncbi.nlm.nih.gov/26256938