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NCT Number: NCT06755632

Screening of Patients With Hepatic Fibrosis or Cirrhosis 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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avicenne Hospital, Bobigny, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

TROD (rapid diagnostic orientation test) and FibroScan®

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

Primary outcomes

  1. Prevalence of significant hepatic fibrosis in the general population of Seine Saint Denis

    Time frame: Two year of inclusion period

Secondary outcomes

  1. Chronic hepatitis B prevalence

    Time frame: Two year of inclusion period

  2. Chronic hepatitis C prevalence

    Time frame: Two year of inclusion period

  3. Proportion of eligible patients for management of viral hepatitis B and C

    Time frame: Two year of inclusion period

    Proportion of eligible patients for management of viral hepatitis B and C

  4. Prevalence of other causes of chronic liver disease (alcohol and NASH)

    Time frame: Two year of inclusion period

  5. Proportion of patients managed in hepatology department after screening for significant fibrosis

    Time frame: Two year of inclusion period

  6. Prevalence of confirmed significant liver fibrosis in patients referred to hepatology consultation

    Time frame: Two years of inclusion period

    This criterion will be assessed based on follow-up FibroScan results, non-invasive fibrosis blood tests, and/or liver biopsy when indicated, in accordance with current hepatology guidelines.

  7. Proportion of patients with ultrasound signs of cirrhosis and hepatocellular carcinoma among patients referred to hepatology consultation (managed according to current hepatology guidelines).

    Time frame: Two years of inclusion period

    This criterion will be assessed based on abdominal ultrasound findings according to current hepatology guidelines.

Study contacts

Contact information is provided by the study sponsor or research team.

Veronique GRANDO, MD-PhD

CONTACT

[email protected]

01 48 02 68 03 ext. +0033

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: DEP-CB

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 1, 2025
Registry last updated
Jul 23, 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.

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