About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Single group
Treatments tested in this trial
Community screening for hepatitis B, C and delta in the Mongolian population living in France
Diagnostic testScreening 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
Information on preventing viral hepatitis
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
Evaluation of hepatic fibrosis using biological test by FibroTest
Characterisation of liver fibrosis in patients with chronic viral hepatitis
Evaluation of hepatic fibrosis using elastometry and biological test by FibroTest
Sponsors and contacts
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