Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation
NCT ID: NCT02967120
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
265 participants
OBSERVATIONAL
2014-01-31
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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p16 hydroxymethylation status
patients with p16 hydroxymethylation
no intervention
Interventions
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no intervention
Eligibility Criteria
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Inclusion Criteria
* No local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips;
* Without the treatment history by laser , radiation or chemical;
* Be able to Sign the informed consent;
Exclusion Criteria
* 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;
25 Years
ALL
No
Sponsors
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Peking University
OTHER
Beijing Municipal Administration of Hospitals
OTHER_GOV
Responsible Party
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Zhaojun Liu
PhD
Principal Investigators
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Dajun Deng, MD
Role: STUDY_DIRECTOR
Peking University Cancer Hosptial and Institute
Locations
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Peking University Cancer Hosptial and Institute
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Liu H, Liu XW, Dong G, Zhou J, Liu Y, Gao Y, Liu XY, Gu L, Sun Z, Deng D. P16 Methylation as an Early Predictor for Cancer Development From Oral Epithelial Dysplasia: A Double-blind Multicentre Prospective Study. EBioMedicine. 2015 Mar 23;2(5):432-7. doi: 10.1016/j.ebiom.2015.03.015. eCollection 2015 May.
Cao J, Zhou J, Gao Y, Gu L, Meng H, Liu H, Deng D. Methylation of p16 CpG island associated with malignant progression of oral epithelial dysplasia: a prospective cohort study. Clin Cancer Res. 2009 Aug 15;15(16):5178-83. doi: 10.1158/1078-0432.CCR-09-0580. Epub 2009 Aug 11.
Liu H, Liu Z, Liu XW, Xu S, Wang L, Liu Y, Zhou J, Gu L, Gao Y, Liu XY, Shi H, Sun Z, Deng D. A similar effect of P16 hydroxymethylation and true-methylation on the prediction of malignant transformation of oral epithelial dysplasia: observation from a prospective study. BMC Cancer. 2018 Sep 24;18(1):918. doi: 10.1186/s12885-018-4787-6.
Other Identifiers
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XM201303
Identifier Type: -
Identifier Source: org_study_id