An interventional study of Community screening for hepatitis B, C and delta in the Mongolian population living in France in HEPATITIS C (HCV), Hepatitis B Virus (HBV) and Hepatitis D, sponsored by Hospices Civils de Lyon. Not yet recruiting at 11 sites in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
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.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
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Exclusion Criteria:
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.
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.
Number of patients positive for hepatitis B, hepatitis C and hepatitis D.
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.
Time frame: Visit 2 (Day 0 to Mounth 4)
Cascade of care for this screening strategy
Number of people tested positive for HBV, HCV or HDV who had a serological test, virological and elastometric evaluation, and hepatology consultation
Time frame: 12 months after positive TROD screening
Information on preventing viral hepatitis
Number of Mongolian people attending the information and prevention session offered on each screening day
Time frame: Baseline
Characterisation of liver fibrosis in patients with chronic viral hepatitis
Evaluation of hepatic fibrosis using biological test by FibroTest
Time frame: Day 1 or up to 4 months
Characterisation of liver fibrosis in patients with chronic viral hepatitis
Evaluation of hepatic fibrosis using elastometry and biological test by FibroTest
Time frame: 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.
Risk of hepatocellular carcinoma in patients positive for viral hepatitis
Evaluation of hepatocellular carcinoma (HCC) risk by biology (AFP)
Time frame: Day 1 or up to 4 months
Risk of hepatocellular carcinoma in patients positive for viral hepatitis
Evaluation of hepatocellular carcinoma (HCC) risk by liver imaging (ultrasound or CT (computed tomography) /MRI (magnetic resonance imaging))
Time frame: Day 1 or up to 4 months
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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