A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation
25 Years
78 Years
Both
Moderate Epithelial Dysplasia, Mild Epithelial Dysplasia
Trial Information
A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Principal Investigator
Dajun Deng, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Peking University
Authority:
China: Beijing Municipal Science and Technology Commission
Study ID:
PKUSSOM20120711
NCT ID:
NCT01695018
Start Date:
February 2009
Completion Date:
Related Keywords:
- Moderate Epithelial Dysplasia
- Mild Epithelial Dysplasia
- oral epithelial dysplasia
- p16 methylation
- diagnostic reagents
- early diagnosis
- Hyperplasia
- Carcinoma in Situ
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