Early Diagnosis of Oral Cancer by Detecting p16 Methylation

Completed

• Conditions: Moderate Epithelial Dysplasia; Mild Epithelial Dysplasia

• Registration Number: NCT01695018
• Lead Sponsor: Peking University

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Primary Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation	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.