Early Diagnosis of Oral Cancer by Detecting p16 Methylation

Peking University

Status: Completed

Conditions: Moderate Epithelial Dysplasia; Mild Epithelial Dysplasia

Study type: Observational

Funder types: Other

Identifiers

NCT01695018

PKUSSOM20120711

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 25 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

p16 methylation positive

Description:

48 patients with mild or moderate oral epithelial dysplasia containing methylated p16.

p16 methylation negative

Description:

104 patients with p16 mild or moderate oral epithelial dysplasia NOT containing methylated p16.