Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity With Next-generation Sequencing: From Chronic Infection to End-stage Liver Disease and Liver Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- genetic variants of Hepatitis B
研究概览
简要总结
In this project proposal, the investigators will investigate the genetic alterations of Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver disease. Additionally, the investigators will compare and link these data sets with three genetic factors involved in immune system response.
详细描述
This project proposes to identify and characterize the genetic alterations associated with intra-host evolution of HBV from a chronically infection status to an end-stage liver disease status.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study group:
- •Clinical diagnosis of advanced liver disease related to chronic Hepatitis B infection (cirrhosis, hepatocellular carcinoma,..)
- •Availability of serum samples
- •Control group:
- •Clinical diagnosis of liver disease related to chronic Hepatitis B infection in a pre-advanced stage
- •Matched demographic and geographic characteristics to study group
- •Availability of serum samples
排除标准
- •Liver disease caused by other hepato-tropic viruses
- •Patients with auto-immune diseases
结局指标
主要结局
genetic variants of Hepatitis B
时间窗: 6 months
Virus variants will be identified by amino acid or nucleotide variations (insertions or deletions) in different Open Readind Frames (ORFs) of the HBV genome by using next-generation sequencing. Comparison of virus variants within one patient Comparison of virus variants between patients with end stage liver disease and patients with a chronic Hepatitis B infection. Determination of the viral load by quantitative Polymerase Chain Reaction (PCR).
次要结局
- genetic variation in host-specific immune markers(at day of enrollment)
研究者
MahmoudReza Pourkarim
PhD
Universitaire Ziekenhuizen KU Leuven