Spots Global Cancer Trial Database for Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

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Trial Identification

Brief Title: Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

Official Title: A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation

Study ID: NCT02967120

Conditions

Oral Epithelial Dysplasia

Interventions

no intervention

Study Description

Brief Summary: The purpose of this study is to verify the function of p16 hydroxymethylation diagnostic reagents in early diagnosis of oral cancer.

Detailed Description: 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.