Community Screening for Hepatitis B, C and Delta in the Mongolian Population Living in France
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 11
- 主要终点
- Number of patients positive for hepatitis B, hepatitis C and hepatitis D.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Screening group
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.
干预措施: Community screening for hepatitis B, C and delta in the Mongolian population living in France (Diagnostic Test)
结局指标
主要结局
Number of patients positive for hepatitis B, hepatitis C and hepatitis D.
时间窗: 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.
次要结局
- Risk of hepatocellular carcinoma in patients positive for viral hepatitis(Day 1 or up to 4 months)
- 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(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.)
- Characterisation of liver fibrosis in patients with chronic viral hepatitis(Day 1 or up to 4 months)