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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест Community 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

Первичные конечные точки

• Number of patients positive for hepatitis B, hepatitis C and hepatitis D. [Срок оценки: Visit 2 (Day 0 to Mounth 4)]

Вторичные конечные точки (6)

• Cascade of care for this screening strategy [Срок оценки: 12 months after positive TROD screening]
• Information on preventing viral hepatitis [Срок оценки: Baseline]
• Characterisation of liver fibrosis in patients with chronic viral hepatitis [Срок оценки: Day 1 or up to 4 months]
• Characterisation of liver fibrosis in patients with chronic viral hepatitis [Срок оценки: 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 [Срок оценки: Day 1 or up to 4 months]
• Risk of hepatocellular carcinoma in patients positive for viral hepatitis [Срок оценки: Day 1 or up to 4 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 11 центров

• Centre Hospitalier Annecy Genevois — Annecy
• Centre Expert Hépatites Virales Aquitaine, CHU de Bordeaux — Bordeaux
• CHU de Clermont Ferrand — Clermont-Ferrand
• Hôpital Henri Mondor - Assistante Publique Hopitaux de Paris (APHP) — Créteil
• CHU Grenoble Alpes — Grenoble
• CHRU Lille — Lille
• Service d'Hépatologie, Institut d'hépatologie de Lyon, Hôpital Croix-Rousse, Hospices Civi — Lyon
• CHRU Rennes Pontchaillou — Rennes
• … и ещё 3 центра

Идентификаторы

NCT: NCT07038863 · 69HCL24_0469 · 2025-A00086-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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