Oral Epithelial Dysplasia Clinical Trial
Official title:
A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation
The purpose of this study is to verify the function of p16 hydroxymethylation diagnostic reagents in early diagnosis of oral cancer.
Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among
Chinese adults. To investigate the clinical predictive value of p16 hydroxymethylation
diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the
prospective multi-center double-blind cohort study.
Methods:265 patients with histologically confirmed mild or moderate OED were included in the
present study. After the bisulfite modification and tet assistant bisulfite modification,
MethyLight and Methylation-specific PCR (MSP) assays were used to analyze p16 methylation and
status in these patients. Building three follow-up queue by p16-methylated,
p16-hydroxymethylation and p16-unmethylated. The Statistical analysis used SPSS16.0. All
P-values were two-sided. P<0.05 was considered to test for statistical significance
difference.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04153266 -
Oral Epithelial Dysplasia Informational Needs Questionnaire
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| Enrolling by invitation |
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N/A | |
| Recruiting |
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