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Completed

NCT Number: NCT04568512

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

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

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Biliary Stricture Brush Cytology Carcinoma DNA Methylation Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Siriraj hospital

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Patient had other malignancy

Treatment and study plan

Control

Diagnostic Test

Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology

Cholangiocarcinoma

Diagnostic Test

Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology

Primary outcomes

  1. 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 outcomes

  1. Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma

    Time frame: 2 weeks

    Diagnostic accuracy of methylation index for diagnosis of cholangiocarcinoma was analyzed.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: DNA

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2020
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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