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

NCT ID: NCT04568512

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Cholangiocarcinoma Biliary Stricture DNA Methylation Brush Cytology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIAGNOSTIC_TEST

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

Cholangiocarcinoma

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

Group Type ACTIVE_COMPARATOR

Cholangiocarcinoma

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Control

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

Cholangiocarcinoma

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* Patient had other malignancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Varayu Prachayakul

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of medicine, Siriraj hospital

Bangkok Noi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 34265285 (View on PubMed)

Other Identifiers

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149/2559

Identifier Type: -

Identifier Source: org_study_id

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