Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France

Not Applicable

Not yet recruiting

• Conditions: HEPATITIS C (HCV); Hepatitis B Virus (HBV); Hepatitis D; Hepatocellular Carcinoma (HCC); Liver Fibrosis

• Registration Number: NCT07038863
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

In Mongolia, mortality from hepatocellular carcinoma (HCC) is one of the highest in the world. Viral hepatitis is the main cause of HCC: the prevalence of hepatitis B (HBV) estimated at 11% In Mongolia, hepatitis C (HCV) at 8.5%, and hepatitis Delta (HDV) at 40-60% in HBV-infected patients. Viral hepatitis are essentially asymptomatic and therefore require systematic screening for diagnosis. Once a diagnosis of chronic viral infection has been established, specific therapies are available to reduce the morbidity and mortality of these patients. A study carried out in California in the Mongolian community found an HBV prevalence of 9.7% and positive HDV serology in 41% of these patients.

There is a large Mongolian community in France, estimated at between 5,000 and 6,000 patients. Although the majority of these patients are covered by French social security; however, access to care and screening for viral hepatitis often remain difficult and insufficient for migrant or vulnerable populations in France The aim of this study is to screen the Mongolian community in France for viral hepatitis, and then initiate a program of care and treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-13
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-09-01
• Primary Completion: 2027-09-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Mongolian people
• Over 15 years of age
• Living in France
• Majors agree to participate or minors whose parental guardians agree to their child's participation in the study

Exclusion Criteria

• People already followed for viral hepatitis, treated or not treated
• Persons deprived of their liberty by a judicial or administrative decision
• Adults subject to a legal protection measure (guardianship, curators)
• People participate in any interventional research except routine care research (old regulation) and category 2 research that does not interfere with the primary endpoint analysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients positive for hepatitis B, hepatitis C and hepatitis D.	Visit 2 (Day 0 to Mounth 4)	Number of patients with positive HBsAg (for HBV), positive serum HCV viral load (for HCV) and serum positive Delta viral load (for HDV) compared with all patients screened.

Secondary Outcome Measures

Name	Time	Method
Cascade of care for this screening strategy	12 months after positive TROD screening	Number of people tested positive for HBV, HCV or HDV who had a serological test, virological and elastometric evaluation, and hepatology consultation
Information on preventing viral hepatitis	Baseline	Number of Mongolian people attending the information and prevention session offered on each screening day
Characterisation of liver fibrosis in patients with chronic viral hepatitis	Liver fibrosis will be assessed by elastometry and a FibroTest blood test, carried out according to the procedures of each centre, either during screening or at the specialist consultation.	Evaluation of hepatic fibrosis using elastometry and biological test by FibroTest
Risk of hepatocellular carcinoma in patients positive for viral hepatitis	Day 1 or up to 4 months	Evaluation of hepatocellular carcinoma (HCC) risk by liver imaging (ultrasound or CT (computed tomography) /MRI (magnetic resonance imaging))

Trial Locations

Locations (11)

Centre Hospitalier Annecy Genevois; 🇫🇷 Annecy, France

Centre Expert Hépatites Virales Aquitaine, CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

Hôpital Henri Mondor - Assistante Publique Hopitaux de Paris (APHP); 🇫🇷 Créteil, France

CHU Grenoble Alpes; 🇫🇷 Grenoble, France

CHRU Lille; 🇫🇷 Lille, France

Service d'Hépatologie, Institut d'hépatologie de Lyon, Hôpital Croix-Rousse, Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHRU Rennes Pontchaillou; 🇫🇷 Rennes, France

CHU de Rouen; 🇫🇷 Rouen, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

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