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Validation of DNA Methylation Biomarkers for Oral Cancer Detection

NCT ID: NCT01945697

Last Updated: 2017-12-26

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

Total Enrollment

267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Cancer

Keywords

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DNA methylation, biomarkers, oral cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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normal oral mucosa

No interventions assigned to this group

oral precancerous lesion or oral cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subject with age over 20.
* Subject agrees to sign the informed consent form.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shih-Jung Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dentistry National Taiwan University Hospital

Locations

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Department of Dentistry National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201207019

Identifier Type: -

Identifier Source: org_study_id