Back to resultsDNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture (DNA)
Primary Purpose
Cholangiocarcinoma, Biliary Stricture, DNA Methylation
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Control
Cholangiocarcinoma
Sponsored by
About this trial
This is an interventional diagnostic trial for Cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Age more than 18 year old
- Patients had biliary stricture from cholangiocarcinoma and benign stricture
Exclusion Criteria:
- Pregnancy
- Patient had other malignancy
Sites / Locations
- Faculty of medicine, Siriraj hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Cholangiocarcinoma
Arm Description
Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma
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
Diagnostic accuracy of methylation index was compared to routine brush cytology.
Full Information
NCT ID
NCT04568512
First Posted
September 23, 2020
Last Updated
September 23, 2020
Sponsor
Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT04568512
Brief Title
DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
Acronym
DNA
Official Title
DNA Methylation Biomarker in Biliary Brush Sample for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Biliary Stricture, DNA Methylation, Brush Cytology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
Arm Title
Cholangiocarcinoma
Arm Type
Active Comparator
Arm Description
Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology
Intervention Type
Diagnostic Test
Intervention Name(s)
Control
Intervention Description
Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
Intervention Type
Diagnostic Test
Intervention Name(s)
Cholangiocarcinoma
Intervention Description
Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology
Primary Outcome Measure Information:
Title
The methylation of HOXA1, NEUROG1 were determined in brushed biliary samples from patients with CCAs compared to those of nonmalignant bile duct stricture
Description
Methylation index of biliary brush samples were analyzed.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma
Description
Diagnostic accuracy of methylation index for diagnosis of cholangiocarcinoma was analyzed.
Time Frame
2 weeks
Title
To compared sensitivity, specificity of DNA methylation with routine cytology of biliary brushed samples
Description
Diagnostic accuracy of methylation index was compared to routine brush cytology.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age more than 18 year old
Patients had biliary stricture from cholangiocarcinoma and benign stricture
Exclusion Criteria:
Pregnancy
Patient had other malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Varayu Prachayakul
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Siriraj hospital
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34265285
Citation
Prachayakul V, Rugivarodom M, Nopjaroonsri P, Cheirsilpa K, Chang A, Kamolhan T, Boonyaarunnate T, Thuwajit C, Thuwajit P. Diagnostic power of DNA methylation markers suggestive of cholangiocarcinoma in ERCP-based brush cytology. Gastrointest Endosc. 2022 Jan;95(1):123-130.e1. doi: 10.1016/j.gie.2021.07.005. Epub 2021 Jul 12.
Results Reference
derived
Learn more about this trial
DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
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