Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oral Cancer
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 267
- Locations
- 1
- Primary Endpoint
- DNA methylation labeled
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject with age over
- •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.
Outcomes
Primary Outcomes
DNA methylation labeled
Time Frame: 2 years
To validate the association between the methylation genes and the oral cancer