Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT01695018
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2012-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Diagnosis of Oral Cancer by Detecting p16 Methylation
Sponsor:
Peking University
Organization:
Study Overview
Official Title:
A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: