Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06366425

Screening for Chronic Liver Diseases in General Population

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Fibrosis, Liver Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Fatty Liver Fibrosis Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample then fibroscan

Diagnostic Test

The patient takes a blood test if none less than 6 months old is available, including a complete blood count (CBC) and a hepatic check. The FIB-4 score will be calculated from this blood test.

If the result of the FIB-4 test is greater than 1.3 the person will be contacted by the SELHV (Service Expert de Lutte contre les Hépatites Virales) of the University Hospital of Montpellier in order to schedule, if she wishes, a second non-invasive screening examination of liver fibrosis by Fibroscan.

Primary outcomes

  1. Evaluation of the liver fibrosis screening acceptability (FIB-4)

    Time frame: During the inclusion assessment at day 1 (Visit 0)

    percentage of patients who agreed to a FIB-4 blood test among all included patients offered screening.

  2. Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan)

    Time frame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)

    percentage of patients who agreed to a FIB-4 blood test FIB-4 followed by Fibroscan (if FIB-4 score>1.3) among all included patients offered screening.

Secondary outcomes

  1. Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>1.3

    Time frame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)

    If FIB-4 Score>1.3 a pulse elastometry (Fibroscan®) will be performed. A fibrotest measurement of ≥10 KPa (Kilopascals) or a score ≥F3 will be considered as advanced hepatic fibrosis.

  2. Prevalence of excessive consumption of alcohol

    Time frame: During the inclusion assessment at day 1 (Visit 0)

    Excessive alcohol consumption will be evaluated by the AUDIT-C questionnaire (Alcohol Use Disorders Identification Test) with a score ranging from 0 (lower risk) to 12 (higher risk of misuse), a score of > or = 3 for women and > or = 4 for men indicates misuse.

  3. Prevalence of a history or drug use

    Time frame: During the inclusion assessment at day 1 (Visit 0)

    Rate of participants with a history or current use of drugs among included patients.

    Answered by the patient face to face with the doctor.

  4. The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders)

    Time frame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)

    The correlation will be evaluated by the rate of patients with risk factors for liver disease and advanced fibrosis, among all those who underwent Fibroscan.

    A fibrotest measurement of ≥10 KPa (Kilopascals) or a score ≥F3 will be considered as advanced hepatic fibrosis

    The presence of metabolic syndrom if at least 3 of the following risk factors are present : arterial hypertension (≥ 130/85 mmHg), hypertriglyceridemia (≥ 1.7 mmol/L), low HDL-cholesterol (Men< 1 mmol/L; women < 1.3 mmol/L) , android obesity (≥ 102 cm men; ≥ 88 cm women) and fasting hyperglycemia (> 100 mg/dL)

    Presence of an alcohol use disorders : AUDIT-C questionnaire with a score of ≥ 3 for women and ≥ 4 for men indicates misuse.

    Presence of diabetes in medical records.

    Presence of hepatitis by using a serology blood test (Hepatitis C Virus : HCV RNA, surface antigen of the hepatitis B virus : HBsAg, anti HBsAg, anti HBCAg, HBV DNA, HBeAg, anti HBeAg, Delta virus in case of hepatitis B positivity).

  5. prevalence of viral hepatitis

    Time frame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)

    Diagnosis of hepatitis by using a rapid diagnostic orientation test (TROD) by collecting of a drop of blood from the fingertip which is placed on a plate with a reactive solution in order to establish the presence of antigens and/or with a serology blood test (( Hepatitis C Virus : HCV RNA, HCV+, surface antigen of the hepatitis B virus : HBsAg, anti HBsAg, anti HBCAg, HBV DNA, HBeAg, anti HBeAg, Delta virus in case of hepatitis B positivity).

    Prevalence of viral hepatitis among all included patients.

  6. Description of socio-demographic characteristics of participants

    Time frame: During the inclusion assessment at day 1 (Visit 0)

    Description of the socio-demographic characteristics of people benefiting from an assessment of liver fibrosis by transient elastometry (Fibroscan®) as part of the study.

    Socio-demographic characteristics will be collected by a patient questionnaire (age, education, profession, income, health insurance, marital status, housing, living conditions) realised face to face with the doctor.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Medical office Aniane
  • Medical office Clermont-Hérault
  • Medical office Montpeyroux
  • On-call medical home (MMG) Clermont-Hérault

Registry information

Official study title

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

Acronym: HEPGEN

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Apr 15, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.