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NCT Number: NCT07038863

Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France

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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Key information

Conditions

HEPATITIS C (HCV) Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Fibrosis Flaviviridae Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B Virus (HBV) Hepatitis C Hepatitis D Hepatitis, Viral, Human Hepatocellular Carcinoma (HCC) Infections Liver Cirrhosis Liver Diseases Liver Fibrosis Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Annecy Genevois, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of patients positive for hepatitis B, hepatitis C and hepatitis D.

    Time frame: 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 outcomes

  1. Cascade of care for this screening strategy

    Time frame: 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

  2. Information on preventing viral hepatitis

    Time frame: Baseline

    Number of Mongolian people attending the information and prevention session offered on each screening day

  3. Characterisation of liver fibrosis in patients with chronic viral hepatitis

    Time frame: Day 1 or up to 4 months

    Evaluation of hepatic fibrosis using biological test by FibroTest

  4. Characterisation of liver fibrosis in patients with chronic viral hepatitis

    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.

    Evaluation of hepatic fibrosis using elastometry and biological test by FibroTest

  5. Risk of hepatocellular carcinoma in patients positive for viral hepatitis

    Time frame: Day 1 or up to 4 months

    Evaluation of hepatocellular carcinoma (HCC) risk by biology (AFP)

  6. Risk of hepatocellular carcinoma in patients positive for viral hepatitis

    Time frame: Day 1 or up to 4 months

    Evaluation of hepatocellular carcinoma (HCC) risk by liver imaging (ultrasound or CT (computed tomography) /MRI (magnetic resonance imaging))

Study contacts

Contact information is provided by the study sponsor or research team.

François BAILLY, Dr

CONTACT

[email protected]

+33 4 26 73 27 33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Community Screening for Hepatitis B, C and Delta in the Mongolian Population Living in France

Acronym: Mondelta

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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