Early Diagnosis of Oral Cancer by Detecting p16 Methylation

September 24, 2014 updated by: Hongwei Liu, MD, PhD, Peking University

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

180 patients with mild or moderate oral epithelial dysplasia were selected. 81 of them were from Peking University of Stomatology and 68 were from Capital Medical University School of Stomatology and other 31 were from Fourth Military Medical University School of Stomatology.All of the patients with OED had been diagnosed pathologically by at least two senior pathologists using the criteria from '2005 WHO Classification System' and The oral tissue pathology diagnostic criteria (oral histopathology Edition Sixth).All cases involved primary lesions without any LASER, radiation therapy or chemotherapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
p16 methylation positive
48 patients with mild or moderate oral epithelial dysplasia containing methylated p16.
p16 methylation negative
104 patients with p16 mild or moderate oral epithelial dysplasia NOT containing methylated p16.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Principal Investigator: Dajun Deng, MD, Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUSSOM20120711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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