DNA Methylation Biomarker in Biliary Brush Sample for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- The methylation of HOXA1, NEUROG1 were determined in brushed biliary samples from patients with CCAs compared to those of nonmalignant bile duct stricture
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
Intervention: Control (Diagnostic Test)
Cholangiocarcinoma
Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology
Intervention: Cholangiocarcinoma (Diagnostic Test)
Outcomes
Primary Outcomes
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
- Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma(2 weeks)
- To compared sensitivity, specificity of DNA methylation with routine cytology of biliary brushed samples(2 weeks)