Early Diagnosis of Oral Cancer by Detecting p16 Methylation

Mild Epithelial Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695018
• Other study ID #: PKUSSOM20120711
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: September 24, 2014
• Start date: February 2009

Study information

• Verified date: September 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 78 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma in Situ
• Mild Epithelial Dysplasia
• Moderate Epithelial Dysplasia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Peking University