Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2026-06-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

City-hospital Collaboration for the Early Screening of Hepatic Fibrosis in Primary Care: a Secondary Prevention Project in the Grenoble Health Basin

NCT07031089

Liver Fibrosis

NOT_YET_RECRUITING

FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease

NCT00708617

Alcoholic Liver Disease

COMPLETED

Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care

NCT06119997

Hepatic Fibrosis

NOT_YET_RECRUITING

LIVER FIBROSIS PREVALENCE IN FRANCE

NCT01927133

Liver Fibrosis Progression in Chronic Liver Disease

UNKNOWN

Screening for Chronic Liver Diseases in General Population

NCT06366425

Fibrosis, Liver

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Pathology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients of a municipal health center who visit the municipal health center on a given day.

Group Type EXPERIMENTAL

TROD (rapid diagnostic orientation test) and FibroScan®

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No