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

Overview

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

Full Title of Study: “DNA Methylation Biomarker in Biliary Brush Sample for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2019

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.

Interventions

  • Diagnostic Test: Control
    • Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
  • Diagnostic Test: Cholangiocarcinoma
    • Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology

Arms, Groups and Cohorts

  • Placebo Comparator: Control
    • Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
  • Active Comparator: Cholangiocarcinoma
    • Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma
    • Time Frame: 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
    • Time Frame: 2 weeks
    • Diagnostic accuracy of methylation index was compared to routine brush cytology.

Participating in This Clinical Trial

Inclusion Criteria

  • Age more than 18 year old – Patients had biliary stricture from cholangiocarcinoma and benign stricture Exclusion Criteria:

  • Pregnancy – Patient had other malignancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Varayu Prachayakul, Principal Investigator, Mahidol University

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