Early Diagnosis of Oral Cancer by Detecting p16 Methylation

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

Detailed Description
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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.

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

Conditions
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Moderate Epithelial Dysplasia, Mild Epithelial Dysplasia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| p16 methylation positive<br>48 patients with mild or moderate oral epithelial dysplasia containing methylated p16. | |
| p16 methylation negative<br>104 patients with p16 mild or moderate oral epithelial dysplasia NOT containing methylated p16. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation | 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. | frome 3 months to 63 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral epithelial dysplasia, p16 methylation, diagnostic reagents, early diagnosis