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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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DNA Methylation, Cholangiocarcinoma, Biliary Stricture, Brush Cytology

Intervention / Treatment
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* Diagnostic Test: Control
* Diagnostic Test: Cholangiocarcinoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 18 year old Patients had biliary stricture from cholangiocarcinoma and benign stricture Exclusion Criteria: Pregnancy Patient had other malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology | Diagnostic Test: Control<br>* Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology<br>|
| Active Comparator: Cholangiocarcinoma<br>Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology | Diagnostic Test: Cholangiocarcinoma<br>* Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The methylation of HOXA1, NEUROG1 were determined in brushed biliary samples from patients with CCAs compared to those of nonmalignant bile duct stricture | Methylation index of biliary brush samples were analyzed. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma | Diagnostic accuracy of methylation index for diagnosis of cholangiocarcinoma was analyzed. | 2 weeks | 
| To compared sensitivity, specificity of DNA methylation with routine cytology of biliary brushed samples | Diagnostic accuracy of methylation index was compared to routine brush cytology. | 2 weeks |