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Early Diagnosis of Oral Cancer by Detecting p16 Methylation

This study has been completed.
Information provided by (Responsible Party):
Hongwei Liu, MD, PhD, Peking University Identifier:
First received: September 25, 2012
Last updated: September 24, 2014
Last verified: September 2014
The purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer.

Moderate Epithelial Dysplasia
Mild Epithelial Dysplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation

Resource links provided by NLM:

Further study details as provided by Peking University:

Primary Outcome Measures:
  • 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.

Biospecimen Retention:   Samples With DNA
Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced and hematoxylin-eosin (HE) staining.

Enrollment: 180
Study Start Date: February 2009
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.

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.


Ages Eligible for Study:   25 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01695018

Sponsors and Collaborators
Peking University
Principal Investigator: Dajun Deng, MD Peking University
  More Information

Additional Information:
Responsible Party: Hongwei Liu, MD, PhD, Peking University School and Hospital of Stomatology, Peking University Identifier: NCT01695018     History of Changes
Other Study ID Numbers: PKUSSOM20120711
Study First Received: September 25, 2012
Last Updated: September 24, 2014

Keywords provided by Peking University:
oral epithelial dysplasia
p16 methylation
diagnostic reagents
early diagnosis

Additional relevant MeSH terms:
Carcinoma in Situ
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms processed this record on May 25, 2017