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ClinicalTrials.gov ID

NCT07038863

Lead Sponsor

Hospices Civils de LyonOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

2,000Estimated

Last Update Posted

Jun 26, 2025Actual

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Sep 1, 2027Estimated

Completion Date

May 1, 2028Estimated

Official Title

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

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.

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

• Community screening for hepatitis B, C and delta in the Mongolian population living in France

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Hospices Civils de LyonOTHER

aabergel@chu-clermontferrand.fr+33 4 73 75 05 23

MNHilleret@chu-grenoble.fr+33 4 76 76 62 57

p-mathurin@chru-lille.fr+33 3 20 44 55 97

caroline.jezequel@chu-rennes.fr+33299284298

Ghassan.Riachi@chu-rouen.fr+33 2 32 88 66 33

antonio.saviano@chru-strasbourg.fr+33 3 69 55 16 04

L.DALTEROCHE@chu-tours.fr+33 2 47 47 59 16