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临床试验/NCT04568512
NCT04568512已完成不适用

DNA Methylation Biomarker in Biliary Brush Sample for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture

Mahidol University2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
2
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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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