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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT04568512
Collaborator
(none)
67
Enrollment
1
Location
2
Arms
48
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Control
  • Diagnostic Test: Cholangiocarcinoma
 N/A

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
Actual Enrollment :
67 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
DNA Methylation Biomarker in Biliary Brush Sample for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma [2 weeks]

    Diagnostic accuracy of methylation index for diagnosis of cholangiocarcinoma was analyzed.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of medicine, Siriraj hospital Bangkok Noi Bangkok Thailand 10700

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Varayu Prachayakul, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT04568512
Other Study ID Numbers:
  • 149/2559
First Posted:
Sep 29, 2020
Last Update Posted:
Sep 29, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cholangiocarcinoma
Constriction, Pathologic

Study Results

No Results Posted as of Sep 29, 2020