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

Cholangiocarcinoma Clinical Trial

— DNA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568512
• Other study ID #: 149/2559
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age more than 18 year old

• Patients had biliary stricture from cholangiocarcinoma and benign stricture

Exclusion Criteria:

• Pregnancy

• Patient had other malignancy

Related Conditions & MeSH terms

• Biliary Stricture
• Brush Cytology
• Cholangiocarcinoma
• Constriction, Pathologic
• DNA Methylation

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of medicine, Siriraj hospital	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma	Diagnostic accuracy of methylation index for diagnosis of cholangiocarcinoma was analyzed.	2 weeks
Secondary	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