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

Civil Hospices of Lyon

Status: Not yet enrolling

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

Treatments: Diagnostic Test: Community screening for hepatitis B, C and delta in the Mongolian population living in France

Study type: Interventional

Funder types: Other

Identifiers

NCT07038863

69HCL24_0469

2025-A00086-43 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Screening group

Experimental group

Description:

This screening study focuses on Mongolian patients living in France. Screening will be organised in 11 centres in France, with 1 to 3 screening sessions per centre: patients will be informed of these screening sessions by the Mongolian Embassy in France, social networks and communities. Screening will be carried out by Rapid Diagnostic Orientation Test (TRODS) for hepatitis B (HBV), hepatitis C (HCV) and hepatitis B (HCV). If the TRODs are positive, a confirmatory serology test will be carried out, followed by specialist hepatology treatment.

Treatment:

Diagnostic Test: Community screening for hepatitis B, C and delta in the Mongolian population living in France