NCT01695018

Early Diagnosis of Oral Cancer by Detecting p16 Methylation

A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 25 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to verify the function of p16 methylation 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 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.

Conditions

• Moderate Epithelial Dysplasia
• Mild Epithelial Dysplasia

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-03-01
• First posted: 2012-09-27
• Last updated: 2014-09-25