NCT00828269已完成1 期
Evaluation of RNA Quality and the Reproducibility of Gene Expression Profiling From Liver Tissue Obtained by Fine Needle Aspiration in Patients With Chronic Hepatitis C.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests.
研究概览
简要总结
The purpose of this study is to evaluate the quality of the RNA and the reproducibility of gene expression profiling from liver tissue samples obtained by fine needle aspiration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has chronic hepatitis C (Genotype 1)
- •Patient has the ability to avoid use of anticoagulants, nonsteroidal anti-inflammatory drugs and aspirin for at least 5 days before the liver biopsy
排除标准
- •Patient has received any approved or investigational drugs for the treatment of hepatitis C in the six months before the liver biopsy
- •Patient has HIV or Hepatitis B virus
- •Patient has been diagnosed with liver cancer
- •Patient has evidence of cirrhosis on any previous liver biopsy
- •Patient has confirmed alcohol abuse in the last 12 months
- •Patient has participated in any investigational drug study within 90 days before the current study
研究组 & 干预措施
1
No Intervention
Liver tissue biopsy
干预措施: Comparator: Fine needle aspiration biopsy (Procedure)
结局指标
主要结局
To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests.
时间窗: 5 weeks
次要结局
- Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.(5 weeks)
研究者
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