Detection of Immune Cell Responses in Chronic HCV Patients Developing Hepatocellular Carcinoma After Treatment With Direct Acting Antiviral Drugs (DAAs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pattern of immunity in patients with de novo HCC develped after treatment with DAAs
研究概览
简要总结
Case control Study to assess the difference of immune cell responses between patients with chronic HCV- related liver cirrhosis who develop HCC after treatment with DAAs and those who do not develop HCC
详细描述
Clinical and laboratory assessment with measurement of Child-Pugh and MELD scores to assess the severity of liver disease and measurement of alpha fetoprotein level for HCC cases will be done.
Radiological assessment using abdominal ultrasound and triphasic CT will be done to determine the extent of the HCC and staging.
Blood sample from all patients will be withdrawn. Plasma will be isolated and stored at - 20C and further analysis for a panel of cytokines, caspases and growth factors using ELISA will be monitored.
Peripheral blood mononuclear cells (PBMCs) will be isolated using ficoll gradient method and will then be stored at -80C.
B and T cell proliferation in response to specific antigens will also be investigated using CFSE staining assay followed by flow cytometry analysis for CD4, CD8 and PD-1.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HCC on top of HCV related liver cirrhosis either received treatment or not
- •Patients without HCC either received treatment or not .
- •Patients with chronic HCV as a control group either received treatment or not.
排除标准
- •Patients with HCC who received any interventional treatment as alcohol injection, radiofrequency , TACE..etc
- •Patients with recurrent HCC after curative treatment.
结局指标
主要结局
Pattern of immunity in patients with de novo HCC develped after treatment with DAAs
时间窗: Two months
Difference of B and T cells immune responses after treatment with DAAs between those who develop HCC and those who do not develop HCC
次要结局
未报告次要终点