NCT07038863

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Community screening for hepatitis B, C and delta in the Mongolian population 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. During this screening visit, Rapid Diagnostic Orientation Test (RDOT) will be carried out to screen for HBV and HCV. If the RDOT is negative for both viruses, an information on transmission and prevention of viral infection will be given. If the RDOT is positive, confirmation of these tests by blood sampling will be organized and complementary biology (ASAT, ALAT, GGT, PAL, bilirubin total, bilirubin conjugated). If HBV RDOT positive, additional tubes will be collected for centralized analysis at the end of the study (VHD DNA, VHD genotyping, fibrotest and LCR1/2 test). Once these confirmatory tests have been carried out, the patient will be referred to a hepatology consultation.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2028-05-01
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

11 sites across 1 country: France