DNA Methylation Biomarker in Biliary Brush Sample for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- The methylation of HOXA1, NEUROG1 were determined in brushed biliary samples from patients with CCAs compared to those of nonmalignant bile duct stricture
研究概览
简要总结
DNA methylation biomarker for diagnosis of cholangiocarcinoma in patients with bile duct stricture has high sensitivity and specificity compared with cytology from the brush specimens
详细描述
The methylation of HOXA1, NEUROG1 were used to determine cholangiocarcinoma from brushed biliary samples. However, the sensitivity and specificity of this test for cholangiocarcinoma is still required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Age more than 18 year old
- •Patients had biliary stricture from cholangiocarcinoma and benign stricture
排除标准
- •Pregnancy
- •Patient had other malignancy
研究组 & 干预措施
Control
Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
干预措施: Control (Diagnostic Test)
Cholangiocarcinoma
Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology
干预措施: Cholangiocarcinoma (Diagnostic Test)
结局指标
主要结局
The methylation of HOXA1, NEUROG1 were determined in brushed biliary samples from patients with CCAs compared to those of nonmalignant bile duct stricture
时间窗: 2 weeks
Methylation index of biliary brush samples were analyzed.
次要结局
- Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma(2 weeks)
- To compared sensitivity, specificity of DNA methylation with routine cytology of biliary brushed samples(2 weeks)