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Recruiting Not applicable

Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C

NCT06755632 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-06-19
Last updated
2026-07-23

Condition(s) studied

Liver Pathology

Investigational drug(s) / intervention(s)

TROD (rapid diagnostic orientation test) and FibroScan®

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Prevalence of significant hepatic fibrosis in the general population of Seine Saint Denis — Two year of inclusion period

Trial sites (2)

FacilityCityRegionStatus
Avicenne Hospital Bobigny France Recruiting
Hepatology department -Hospital Avicenne Bobigny France Withdrawn
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06755632 on ClinicalTrials.gov ↗ ← All trials in France