Early Diagnosis of Oral Cancer by Detecting p16 Methylation
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 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|
- Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation [ Time Frame: frome 3 months to 63 months ] [ Designated as safety issue: No ]
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.
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695018
|Principal Investigator:||Dajun Deng, MD||Peking University|