A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 hydroxymethylation
研究概览
简要总结
The purpose of this study is to verify the function of p16 hydroxymethylation 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 hydroxymethylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.
Methods:265 patients with histologically confirmed mild or moderate OED were included in the present study. After the bisulfite modification and tet assistant bisulfite modification, MethyLight and Methylation-specific PCR (MSP) assays were used to analyze p16 methylation and status in these patients. Building three follow-up queue by p16-methylated, p16-hydroxymethylation and p16-unmethylated. The Statistical analysis used SPSS16.0. 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 —（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 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 hydroxymethylation
时间窗: from 3 months to 60 months
Among these cases, oral specimens from 24 patients were p16-hydroxymethylation, 54 patients were p16-methylation and 187 patients were p16-unmethylation. The cancer rate in the p16-hydroxymethylation patients during the followup period will be compared with that in the other two groups.
次要结局
- Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation(from 3 months and 36 months)
研究者
Zhaojun Liu
PhD
Beijing Municipal Administration of Hospitals