Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

Oral Epithelial Dysplasia Clinical Trial

Official title:

A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967120
• Other study ID #: XM201303
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2016
• Last updated: September 20, 2017
• Start date: January 2014
• Est. completion date: January 2018

Study information

• Verified date: September 2017
• Source: Beijing Municipal Administration of Hospitals
• Contact: Zhaojun Liu, PhD
• Phone: 86-010-88196721
• Email: liuzhaojun[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to verify the function of p16 hydroxymethylation diagnostic reagents in early diagnosis of oral cancer.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 265
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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 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;

Related Conditions & MeSH terms

• Carcinoma in Situ
• Oral Epithelial Dysplasia

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
China	Peking University Cancer Hosptial and Institute	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Municipal Administration of Hospitals	Peking University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 hydroxymethylation	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.	from 3 months to 60 months
Secondary	Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation		from 3 months and 36 months