Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Characterisation of genomic mutations of HCC, developed in HCV patients with SVR
研究概览
简要总结
In this international collaboration study, the research group will analyze somatic mutations of hepatocellular carcinoma (HCC) developed after sustained virological response (SVR) in patients treated with hepatitis C (HCV) therapy
详细描述
Method Paired liver tissue samples will be collected from the tumour sections and also from the adjacent non-tumour tissues, for comparison in each individual. The tissues have been collected as part of routine clinical work/other studies, by liver biopsies or at liver resection/liver transplantation. Data regarding the patient characteristic will be collected. Whole genome sequencing analyses are planned to be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with sustained virological response (SVR) after interferon (IFN)-containing or IFN-free treatment, and developed hepatocellular carcinoma (HCC)
- •Available liver biopsies from hepatocellular carcinoma and non-HCC tissue
排除标准
- •Co-infection with chronic hepatitis B (HBsAg positive) or HIV infection.
- •Liver transplantation prior to treatment-start, leading to SVR.
- •Patients with diagnosed HCC prior to treatment-start, leading to SVR.
结局指标
主要结局
Characterisation of genomic mutations of HCC, developed in HCV patients with SVR
时间窗: 5 years
Genetic characteristics of HCCs will be compared to non-HCC tissue
次要结局
未报告次要终点
研究者
Soo Aleman
MD, PhD, Assoc prof
Karolinska Institutet