Hepatitis B Virus (HBV), HEPATITIS C (HCV), Hepatitis D, Hepatocellular Carcinoma (HCC), Liver Fibrosis
Conditions
Keywords
HBV, HCV, HDV, HCC
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.
Interventions
DIAGNOSTIC_TESTCommunity 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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients positive for hepatitis B, hepatitis C and hepatitis D. | Visit 2 (Day 0 to Mounth 4) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cascade of care for this screening strategy | 12 months after positive TROD screening | 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 | Baseline | 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 | Day 1 or up to 4 months | Evaluation of hepatic fibrosis using biological test by FibroTest |
| Risk of hepatocellular carcinoma in patients positive for viral hepatitis | Day 1 or up to 4 months | Evaluation of hepatocellular carcinoma (HCC) risk by biology (AFP) |
Countries
France
Contacts
Primary ContactFrançois BAILLY, Dr
Outcome results
None listed