Biliary Stricture, Brush Cytology, Cholangiocarcinoma, DNA Methylation
Conditions
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.
Interventions
DIAGNOSTIC_TESTControl
Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
DIAGNOSTIC_TESTCholangiocarcinoma
Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology
Sponsors
Mahidol University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age more than 18 year old * Patients had biliary stricture from cholangiocarcinoma and benign stricture
Exclusion criteria
* Pregnancy * Patient had other malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Thailand
Outcome results
None listed