A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 主要终点
- Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation
研究概览
简要总结
The purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer.
详细描述
Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. To investigate the clinical predictive value of p16 methylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.
Methods:180 patients with histologically confirmed mild or moderate OED were included in the present study. The investigators using p16 methylation diagnostic reagents to analysis of the p16 methylation status in these patients. Building two follow-up queue by p16-methylated and p16-unmethylated. The Statistical analysis used SAS6.12 software. All P-values were two-sided. P<0.05 was considered to test for statistical significance difference.
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
- 25 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological diagnosis of oral lesions meet the epithelial diagnostic criteria for mild to moderate grade OED
- •No local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
- •Without the OCE treatment history by laser , radiation or chemical
- •Be able to Sign the informed consent
排除标准
- •Histopathological diagnosis of oral lesions do not meet the epithelium of mild to moderate dysplasia diagnostic criteria; histological diagnosis of severe grade OED or malignant disease
- •Pregnancy or breast-feeding women
- •Serious heart, lung, liver , kidney and other systemic diseases
- •local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
- •OED treatment history by LASER, radiotherapy, or chemotherapy
- •Tumor and psychiatric patients
- •Patients are unable to cooperate
结局指标
主要结局
Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation
时间窗: frome 3 months to 63 months
152 participants were p16 methylated informative. 29 participants were NOT informative because enough DNA was not extracted from their paraffin slides. Among these informative cases, oral specimens from 48 patients were p16 methylation positive and 104 patients were p16 methylation negative. The cancer rate in the p16 methylation positive patients during the followup period will be compared with that in the p16 methylation negative patients statistically.
次要结局
未报告次要终点
研究者
Hongwei Liu, MD, PhD
Peking University School and Hospital of Stomatology
Peking University