Clinical trial NCT06366425: Screening for Chronic Liver Diseases in General Population
Official title: Non-invasive Screening for Chronic Liver Diseases in the General Population. A Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibrosis, Liver
Keywords: Non-alcoholic fatty liver disease (NAFLD)
Hepatocellular carcinoma (HCC)
Chronic liver diseases
Linkage to care
Fibrosis research
Non-invasive diagnosis
FIB-4
Fibroscan
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: On-call medical home (MMG) Clermont-Hérault
name: Medical office Montpeyroux
name: Medical office Clermont-Hérault
name: Medical office Aniane
First posted: 2024-04-15
Enrollment: 260
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.

Detailed description: The prevalence of chronic liver diseases continues to increase on the one hand by the increase in non-alcoholic fatty liver disease (NAFLD) which affects 25% of the general population as well as the increased incidence of hepatocellular carcinoma in recent years. Screening for liver fibrosis in the general population represents a major public health issue.

The FIB-4 score is obtained by a blood test. This score combines age, measurement of ALT/ASAT (alanine aminotransferase / aspartate-aminotransferase) and platelet count. This score is sensitive for detecting advanced fibrosis liver and allows 71% of patients to avoid a liver biopsy.

Transient elastometry (Fibroscan®) is another very effective non-invasive assessment in the diagnosis of chronic liver diseases and hepatic fibrosis. It has already been demonstrated by several studies that combining several non-invasive fibrosis tests allows to improve the precision of the result.

The investigators hypothesize that offering an additional assessment by Fibroscan for patients screened by a blood test (FIB-4 Score) as possibly having advanced liver fibrosis (Score \>1.3) will raise awareness among professional practitioners and the general population with chronic liver diseases and refine screening for chronic liver diseases.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 40 years
* Without known liver pathologies
* Having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of metabolic syndrome, diabetes or a risk factor for viral hepatitis B, D or C.

Exclusion Criteria:

* Fibroscan already performed in the last 12 months
* Failure to collect express oral consent
* Patient not affiliated with or not benefiting from a national health insurance scheme
* Patient protected by law
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Evaluation of the liver fibrosis screening acceptability (FIB-4)
timeFrame: During the inclusion assessment at day 1 (Visit 0)
measure: Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan)
timeFrame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
Secondary outcomes:
measure: Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>1.3
timeFrame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
measure: Prevalence of excessive consumption of alcohol
timeFrame: During the inclusion assessment at day 1 (Visit 0)
measure: Prevalence of a history or drug use
timeFrame: During the inclusion assessment at day 1 (Visit 0)
measure: The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders)
timeFrame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
measure: prevalence of viral hepatitis
timeFrame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
measure: Description of socio-demographic characteristics of participants
timeFrame: During the inclusion assessment at day 1 (Visit 0)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Magdalena MESZAROS, MD
role: STUDY_DIRECTOR
References:
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