Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

Beijing Municipal Administration of Hospitals265 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

265

Conditions

Oral Epithelial Dysplasia

Interventions

no interventionOTHER

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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 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;

Locations (1)

Peking University Cancer Hosptial and Institute

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 hydroxymethylation

Among these cases, oral specimens from 24 patients were p16-hydroxymethylation, 54 patients were p16-methylation and 187 patients were p16-unmethylation. The cancer rate in the p16-hydroxymethylation patients during the followup period will be compared with that in the other two groups.

Time frame: from 3 months to 60 months

Secondary Outcomes

Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation

Time frame: from 3 months and 36 months

Central Contacts

Zhaojun Liu, PhD

CONTACT

86-010-88196721 liuzhaojun@bjmu.edu.cn

Data from ClinicalTrials.gov

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