Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C (DEP-CB)

June 23, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Out-of-hospital Screening of Patients With Significant Hepatic Fibrosis or Cirrhosis and Viral Hepatitis B and C

Regardless of its etiology (chronic hepatitis B or C, alcohol consumption, metabolic steatohepatitis, hemochromatosis, autoimmune liver disease), cirrhosis is a real public health issue. Cirrhosis is a chronic disease and can get complicated by liver cancer, digestive hemorrhage, or liver failure, which are responsible for morbidity and mortality.

In France, cirrhosis prevalence is estimated at 700,000 patients and induce 16,000 deaths per year (10,000 liver cancer and 6,000 liver decompensation). In Ile-de-France area, cirrhosis prevalence is estimated at 130,000 cases, a lot of them are in Seine Saint Denis department due to precariousness.

Hepatitis C virus can now be cured and hepatitis B treatment can suspend hepatitis B replication. All these treatments reduce liver complications but even after virological cure, cirrhosis requires dedicated long term management as well as alcoholic liver disease and metabolic steatohepatitis at cirrhosis stage.

Periodic screening for complications and specific measures were defined by french HAS in 2007 (medication intake, dietary management and specific vaccinations), especially the performance of a semi-annual liver ultrasound for hepatocellular carcinoma (HCC) screening.

Then, it seems essential to screen for patients with viral hepatitis and extensive fibrosis or cirrhosis in our department to achieve active and individualized management of this chronic liver disease, to reduce long term morbidity and mortality.

The main aim of the study is to evaluate the prevalence of advanced liver fibrosis and viral infections B and C in the general population of Seine Saint Denis, using a dual screening method of TROD (rapid diagnostic orientation test) and FibroScan®, combined with a care pathway

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Targeted population

The targeted population will be users of one municipal health center visiting the municipal health center on a given day We will propose a screening for liver fibrosis using Fibroscan mini® and will propose rapid diagnostic orientation tests (TROD) for HCV and HBV viral infection, by a traveling physician Expérimental scheme

Proposal by the caregiver to each patient at the center :

  • Fibroscan®
  • TROD VHC / VHB IF Fibroscan ≥ 9.6 KPa or positive HCV TROD or HBsAg positive THEN Suggested appointment Avicenne hospital hepatology consultation or Jean Verdier hepatology consultation

Study Type

Interventional

Enrollment (Estimated)

600

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 Locations

  • France
      • Bobigny, France, 93000
        • Recruiting
        • Avicenne Hospital
        • Contact:
      • Bobigny, France, 93100
        • Withdrawn
        • Hepatology department -Hospital Avicenne

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≥18 years
  • Collection of signed consent
  • Patients affiliated to a Social Security System

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Subjects under AME
  • Persons under court protection
  • Guardianship or curatorship,
  • Safeguard of justice
  • Persons under psychiatric care without their consent
  • Persons admitted to a health or social institution for purposes other than research,
  • Patients of full age under legal protection (guardianship or curatorship)
  • Persons unable to express their consent.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients of a municipal health center who visit the municipal health center on a given day.
Diagnostic test: TROD (rapid diagnostic orientation test) and FibroScan®

Fast-track appointment at the hepatology consultation at Avicenne Hospital (Bobigny) or the hepatology consultation at Jean Verdier Hospital (Bondy) for any patient :

  • with Fibroscan® ≥ 9.6 KPa or
  • positive hepatitis C serology or
  • HBsAg positive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of significant hepatic fibrosis in the general population of Seine Saint Denis
Time Frame: One year of inclusion period
One year of inclusion period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic hepatitis B prevalence
Time Frame: One year of inclusion period
One year of inclusion period
Chronic hepatitis C prevalence
Time Frame: One year of inclusion period
One year of inclusion period
Proportion of eligible patients for management of viral hepatitis B and C
Time Frame: One year of inclusion period
Proportion of eligible patients for management of viral hepatitis B and C
One year of inclusion period
Prevalence of other causes of chronic liver disease (alcohol and NASH)
Time Frame: One year of inclusion period
One year of inclusion period
Proportion of patients managed in hepatology department after screening for significant fibrosis
Time Frame: One year of inclusion period
One year of inclusion period

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

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

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 (Actual)

June 19, 2025

Primary Completion (Estimated)

June 2, 2026

Study Completion (Estimated)

June 2, 2026

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP240250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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