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
- 46
- 试验地点
- 1
- 主要终点
- Association between the DNA methylation level and the stage of cancer
研究概览
简要总结
The purpose of this study is to investigate the correlation between DNA methylation and the treatment and recurrence of oral cancer.
详细描述
In this study, investigators plan to recruit 40~50 patients who had, or currently has oral cancer. The study procedures are as below:
- After the Informed Consent Form is signed, swab from the lesion site and normal site to obtain oral epithelial cells.
- Collect tissue from the tumor site and the non-cancerous matched site from the surgery or the tissue bank.
- Collect oral swab from the lesion site and the normal site when patients return to the clinic for a regular follow-up.
Specimens will be collected for DNA methylation testing, and the results will be compared with patient's clinical diagnosis. It is expected that the relationship between DNA methylation, oral cancer, and the recurrence of oral cancer will be found.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 75 years old
- •Had or currently has cancer of the oral cavity
- •Agree to sign the Informed Consent Form (ICF) and comply with follow-up procedures
排除标准
- •Unwilling to sign the Informed Consent Form (ICF)
- •Has an autoimmune disease of the oral cavity
结局指标
主要结局
Association between the DNA methylation level and the stage of cancer
时间窗: 1 year
1. Compare the DNA methylation level and the stage of cancer before treatment. 2. DNA methylation level as a monitor tool for recurrence/metastasis of oral cancer. 3. qPCR will be used to determine the DNA methylation level.
次要结局
未报告次要终点