Oral Epithelial Dysplasia, Mild or Moderate Grade Clinical Trial
Official title:
A Cohort Study on Prediction of Malignant Transformation of Oral Epithelial Dysplasia by p16 Methylation
Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. Biomarker is not available for detection of malignant potential of OED till now. p16 is an important tumor suppressor gene, which is inactivated frequently by methylation of CpG island in early stage of carcinogenesis. The present cohort study is to investigate whether p16 methylation is correlated with malignant transformation of OED.
- Background: Identification of malignant potential of oral epithelial dysplasia (OED) is
virtually impossible on histopathological grounds alone. Inactivation of p16 gene by
CpG methylation is an early frequent event during oral carcinogenesis. To investigate
the predictive value of p16 methylation on malignant potential in OED, we carried out
the prospective cohort study.
- Methods: 101 patients with histologically confirmed mild or moderate OED were included
in the present study. Baseline information of p16 methylation status of the OED lesions
from 93 cases was obtained by methylation-specific PCR. Progression of the OEDs lesions
was examined in 78 cases histologically during the 45.8 months double-blind followup
survey (78/93). The association between p16 methylation and progression of OED was
analyzed with SPSS13.0 software. All P-values were two-sided.
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Observational Model: Cohort, Time Perspective: Prospective