CholangiocarcinomaDNANCT04568512
DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
A study testing Cholangiocarcinoma in people with Cholangiocarcinoma and Biliary Stricture, run by Mahidol University at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Biliary Stricture, DNA Methylation
- What is being tested?
- Cholangiocarcinoma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 year old
- Patients had biliary stricture from cholangiocarcinoma and benign stricture
Who cannot join
- Pregnancy
- Patient had other malignancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of medicine, Siriraj hospital
Bangkok Noi, Bangkok, 10700
About this study
Official title: DNA Methylation Biomarker in Biliary Brush Sample for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
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
Read the 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.
- Conditions
- Cholangiocarcinoma, Biliary Stricture, DNA Methylation, Brush Cytology
- Being tested
- Control, Cholangiocarcinoma
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDiagnostic test
Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
CholangiocarcinomaDiagnostic test
Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology Receives: Diagnostic Test: Control |
| Cholangiocarcinoma | Active comparator | Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology Receives: Diagnostic Test: Cholangiocarcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (2)
Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma
Diagnostic accuracy of methylation index for diagnosis of cholangiocarcinoma was analyzed.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Varayu Prachayakul, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568512
- Sponsor's protocol ID
- 149/2559
- Acronym
- DNA
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34265285
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation Biomarker in Biliary Brush Sample for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
- ClinicalTrials.gov ID
- NCT04568512
- Acronym / sponsor ID
- DNA / 149/2559
- Conditions
- Cholangiocarcinoma, Biliary Stricture, DNA Methylation, Brush Cytology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Diagnostic Test: ControlBrushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology |
| Cholangiocarcinoma | Active comparator | Diagnostic Test: CholangiocarcinomaBrushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 18 year old
- Patients had biliary stricture from cholangiocarcinoma and benign stricture
Key exclusion criteria (2 listed)
- Pregnancy
- Patient had other malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlBrushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology | Diagnostic test | Control |
| CholangiocarcinomaBrushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology | Diagnostic test | Cholangiocarcinoma |
Primary outcome
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.
2 secondary outcomes
Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma
Time frame: 2 weeks
To compared sensitivity, specificity of DNA methylation with routine cytology of biliary brushed samples
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Derived from this study: PubMed 34265285Prachayakul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varayu Prachayakul principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholangiocarcinoma in people with Cholangiocarcinoma and Biliary Stricture, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.