Validation of DNA Methylation Biomarkers for Oral Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- DNA methylation labeled
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with age over
- •Subject agrees to sign the informed consent form.
排除标准
- •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.
结局指标
主要结局
DNA methylation labeled
时间窗: 2 years
To validate the association between the methylation genes and the oral cancer
次要结局
未报告次要终点