Oral CancerNCT01945697
Validation of DNA Methylation Biomarkers for Oral Cancer Detection
An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to evaluate the association between several methylated genes and oral cancers. A prospective case control trial is designed with sample size estimated at least 160 cases. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer
- How many people
- 267 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Sep 2014
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients come to the Department of Dentistry of National Taiwan University Hospital for oral health care or treatment.
Who may be able to join
- Subject with age over 20.
- Subject agrees to sign the informed consent form.
Who cannot join
- Subjects have history of head and neck cancer.
- Subjects have had received chemotherapy for cancers.
- Pregnant Woman
- Subjects whose has oral mucosal lichen planus.
- Subjects whose oral mucosal findings is abnormal, but the diagnosis is unknown.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Dentistry National Taiwan University Hospital
Taipei, 100
About this study
The aim of this study is to evaluate the association between several methylated genes and oral cancers. A prospective case control trial is designed with sample size estimated at least 160 cases. It is expected to enroll at least 100 subjects with precancerous lesion or oral cancer, and ~60 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all of the subjects will receive an intraoral examination and the oral epithelial cells will be collected. If abnormal oral lesion is observed, it will be photographed, and the biopsy will be performed to confirm the diagnosis. For methylated gene detections, the gDNA will be extracted from the collected cells and standardized assay will be performed. Clinical sensitivity and specificity for these methylated genes will be evaluated.
- Conditions
- Oral Cancer
- Keywords
- DNA methylation, biomarkers, oral cancer
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal oral mucosa | Not described | |
| oral precancerous lesion or oral cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA methylation labeled
To validate the association between the methylation genes and the oral cancer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shih-Jung Cheng, MD, Principal investigator, Department of Dentistry National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945697
- Sponsor's protocol ID
- 201207019
- Status last verified
- Sep 2014
- First submitted
- 15 Sep 2013
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of DNA Methylation Biomarkers for Oral Cancer Detection
- ClinicalTrials.gov ID
- NCT01945697
- Acronym / sponsor ID
- 201207019
- Conditions
- Oral Cancer
- Keywords
- DNA methylation, biomarkers, oral cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Sep 2013 (estimated)
- 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.
The aim of this study is to evaluate the association between several methylated genes and oral cancers. A prospective case control trial is designed with sample size estimated at least 160 cases. It is expected to enroll at least 100 subjects with precancerous lesion or oral cancer, and ~60 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all of the subjects will receive an intraoral examination and the oral epithelial cells will be collected. If abnormal oral lesion is observed, it will be photographed, and the biopsy will be performed to confirm the diagnosis. For methylated gene detections, the gDNA will be extracted from the collected cells and standardized assay will be performed. Clinical sensitivity and specificity for these methylated genes will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal oral mucosa | – | – |
| oral precancerous lesion or oral cancer | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients come to the Department of Dentistry of National Taiwan University Hospital for oral health care or treatment.
Key inclusion criteria (2 listed)
- Subject with age over 20.
- Subject agrees to sign the informed consent form.
Key exclusion criteria (5 listed)
- Subjects have history of head and neck cancer.
- Subjects have had received chemotherapy for cancers.
- Pregnant Woman
- Subjects whose has oral mucosal lichen planus.
- Subjects whose oral mucosal findings is abnormal, but the diagnosis is unknown.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DNA methylation labeled
Time frame: 2 years
To validate the association between the methylation genes and the oral cancer
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 26 Dec 2017.
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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.
Shih-Jung Cheng, MD principal investigator
Department of Dentistry National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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 26 Dec 2017. 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 Taiwan. 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. 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?
DNA methylation labeled (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2017.