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

April 12, 2024 updated by: University Hospital, Montpellier

Dépistage Non Invasif Des Maladies Chroniques du Foie en Population générale. Une étude Prospective

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 >2.67) will raise awareness among professional practitioners and the general population with chronic liver diseases and refine screening for chronic liver diseases.

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU de Montpellier
        • Contact:
        • Principal Investigator:
          • Magdalena MESZAROS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Population with a chronic liver disease risk factor
Patient aged ≥ 40 years, with no known liver disease, consulting a general practitioner and having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of a metabolic syndrome, diabetes or a risk factor for viral hepatitis B/D or C.
Diagnostic test: Blood sample then fibroscan

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 2.67 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the inclusion assessment at day 1 (Visit 0)
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>2.67) among all included patients offered screening.
During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>2.67
Time Frame: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
If FIB-4 Score>2.67 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.
During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
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.
During the inclusion assessment at day 1 (Visit 0)
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.
During the inclusion assessment at day 1 (Visit 0)
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).
During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
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.
During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
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.
During the inclusion assessment at day 1 (Visit 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

On-call medical home (MMG) Clermont-Hérault

Investigators

  • Study Director: Magdalena MESZAROS, MD, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL23_0272

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibrosis, Liver

Clinical Trials on Blood sample then fibroscan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe