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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00086-43 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community screening for hepatitis B, C and delta in the Mongolian population living in France | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 (Day 0 to Mounth 4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months after positive TROD screening |
| Information on preventing viral hepatitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François BAILLY, Dr | Contact | +33 4 26 73 27 33 | francois.bailly@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Annecy Genevois | Annecy | France |
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Number of Mongolian people attending the information and prevention session offered on each screening day |
| Baseline |
| Characterisation of liver fibrosis in patients with chronic viral hepatitis | Evaluation of hepatic fibrosis using biological test by FibroTest | 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 | 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) | 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)) | Day 1 or up to 4 months |
| Centre Expert Hépatites Virales Aquitaine, CHU de Bordeaux | Bordeaux | France |
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| CHU de Clermont Ferrand | Clermont-Ferrand | France |
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| Hôpital Henri Mondor - Assistante Publique Hopitaux de Paris (APHP) | Créteil | France |
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| CHU Grenoble Alpes | Grenoble | France |
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| CHRU Lille | Lille | France |
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| Service d'Hépatologie, Institut d'hépatologie de Lyon, Hôpital Croix-Rousse, Hospices Civils de Lyon | Lyon | France |
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| CHRU Rennes Pontchaillou | Rennes | France |
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| CHU de Rouen | Rouen | France |
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| Hôpitaux Universitaires de Strasbourg | Strasbourg | France |
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| CHRU Bretonneau | Tours | France |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006509 | Hepatitis B |
| D003699 | Hepatitis D |
| D006528 | Carcinoma, Hepatocellular |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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