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

Mahidol University

Status: Completed

Conditions: DNA Methylation; Brush Cytology; Biliary Stricture; Cholangiocarcinoma

Treatments: Diagnostic Test: Control; Diagnostic Test: Cholangiocarcinoma

Study type: Interventional

Funder types: Other

Identifiers

NCT04568512

149/2559

Details and patient eligibility

About

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 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy
• Patient had other malignancy

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Diagnostic Test: Control

Cholangiocarcinoma

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Cholangiocarcinoma