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|
Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced and hematoxylin-eosin (HE) staining.
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
patients with mild or moderate oral epithelial dysplasia containing methylated p16.
patients with 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|