Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06755632

Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-24

600

Participants Needed

2

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Signed consent collected
  • Affiliated with a Social Security System
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Avicenne Hospital

Bobigny, France, 93000

Actively Recruiting

2

Hepatology department -Hospital Avicenne

Bobigny, France, 93100

Withdrawn

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Research Team

V

Veronique GRANDO, MD-PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C | DecenTrialz