Clinical trial NCT01695018: Early Diagnosis of Oral Cancer by Detecting p16 Methylation
Official title: A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate Epithelial Dysplasia
Mild Epithelial Dysplasia
Keywords: oral epithelial dysplasia
p16 methylation
diagnostic reagents
early diagnosis
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 180
Sex: ALL
Minimum age (years): 25
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation
timeFrame: frome 3 months to 63 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University
name: Dajun Deng, MD
role: PRINCIPAL_INVESTIGATOR
References: