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

Not Applicable

Completed

• Conditions: Biliary Stricture; Cholangiocarcinoma; DNA Methylation; Brush Cytology
• Interventions: Diagnostic Test: Cholangiocarcinoma; Diagnostic Test: Control

• Registration Number: NCT04568512
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Study First Posted: 2020-09-29
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Age more than 18 year old
• Patients had biliary stricture from cholangiocarcinoma and benign stricture

Exclusion Criteria

• Pregnancy
• Patient had other malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholangiocarcinoma	Cholangiocarcinoma	Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology
Control	Control	Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology

Primary Outcome Measures

Name	Time	Method
The methylation of HOXA1, NEUROG1 were determined in brushed biliary samples from patients with CCAs compared to those of nonmalignant bile duct stricture	2 weeks	Methylation index of biliary brush samples were analyzed.

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma	2 weeks	Diagnostic accuracy of methylation index for diagnosis of cholangiocarcinoma was analyzed.
To compared sensitivity, specificity of DNA methylation with routine cytology of biliary brushed samples	2 weeks	Diagnostic accuracy of methylation index was compared to routine brush cytology.

Trial Locations

Locations (1)

Faculty of medicine, Siriraj hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand