Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation
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|ClinicalTrials.gov Identifier: NCT02967120|
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment|
|Oral Epithelial Dysplasia||Other: no intervention|
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.
|Study Type :||Observational|
|Estimated Enrollment :||265 participants|
|Official Title:||A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
p16 hydroxymethylation status
patients with p16 hydroxymethylation
Other: no intervention
- Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 hydroxymethylation [ Time Frame: from 3 months to 60 months ]Among these cases, oral specimens from 24 patients were p16-hydroxymethylation, 54 patients were p16-methylation and 187 patients were p16-unmethylation. The cancer rate in the p16-hydroxymethylation patients during the followup period will be compared with that in the other two groups.
- Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation [ Time Frame: from 3 months and 36 months ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967120
|Contact: Zhaojun Liu, PhDemail@example.com|
|Peking University Cancer Hosptial and Institute||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Zhaojun Liu, Ph.D 86-010-88196721 firstname.lastname@example.org|
|Contact: Dajun Deng, M.D 86-010-88196752 email@example.com|
|Study Director:||Dajun Deng, MD||Peking University Cancer Hosptial and Institute|