Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France
Mondelta
Community Screening for Hepatitis B, C and Delta in the Mongolian Population Living in France
2 other identifiers
interventional
2,000
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2025
CompletedFirst Posted
Study publicly available on registry
June 26, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
June 26, 2025
June 1, 2025
2 years
March 13, 2025
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (6)
Cascade of care for this screening strategy
12 months after positive TROD screening
Information on preventing viral hepatitis
Baseline
Characterisation of liver fibrosis in patients with chronic viral hepatitis
Day 1 or up to 4 months
Characterisation of liver fibrosis in patients with chronic viral hepatitis
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
Day 1 or up to 4 months
- +1 more secondary outcomes
Study Arms (1)
Screening group
EXPERIMENTALThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Centre Hospitalier Annecy Genevois
Annecy, France
Centre Expert Hépatites Virales Aquitaine, CHU de Bordeaux
Bordeaux, France
CHU de Clermont Ferrand
Clermont-Ferrand, France
Hôpital Henri Mondor - Assistante Publique Hopitaux de Paris (APHP)
Créteil, France
CHU Grenoble Alpes
Grenoble, France
CHRU Lille
Lille, France
Service d'Hépatologie, Institut d'hépatologie de Lyon, Hôpital Croix-Rousse, Hospices Civils de Lyon
Lyon, France
CHRU Rennes Pontchaillou
Rennes, France
CHU de Rouen
Rouen, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
CHRU Bretonneau
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2025
First Posted
June 26, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
June 26, 2025
Record last verified: 2025-06