Brief Title
Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Official Title
Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Brief 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. 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 Type
Observational
Primary Outcome
DNA methylation labeled
Condition
Oral Cancer
Study Arms / Comparison Groups
normal oral mucosa
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
267
Start Date
December 2012
Completion Date
September 2014
Primary Completion Date
September 2014
Eligibility Criteria
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.
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Shih-Jung Cheng, MD, ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT01945697
Organization ID
201207019
Responsible Party
Sponsor
Study Sponsor
National Taiwan University Hospital
Study Sponsor
Shih-Jung Cheng, MD, Principal Investigator, Department of Dentistry National Taiwan University Hospital
Verification Date
September 2014