Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

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ClinicalTrials.gov Identifier: NCT02967120

Recruitment Status : Unknown

Verified September 2017 by Zhaojun Liu, Beijing Municipal Administration of Hospitals.
Recruitment status was: Recruiting

First Posted : November 17, 2016

Last Update Posted : September 25, 2017

Sponsor:

Collaborator:

Peking University

Information provided by (Responsible Party):

Zhaojun Liu, Beijing Municipal Administration of Hospitals

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Oral Epithelial Dysplasia	Other: no intervention

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 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 Design

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Study Type :	Observational
Estimated Enrollment :	265 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Oral Cancer Lip and Oral Cavity Cancer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
p16 hydroxymethylation status patients with p16 hydroxymethylation	Other: no intervention

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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

Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced；or frozen tissues;

Eligibility Criteria

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Ages Eligible for Study:	25 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

336 patients with mild or moderate oral epithelial dysplasia were selected. 145 of them are collected from Peking University of Stomatology and 165 were from Capital Medical University School of Stomatology and other 26 were from Fourth Military Medical University School of Stomatology.All of the patients with OED had been diagnosed pathologically by at least two senior pathologists using the criteria from '2005 WHO Classification System' and The oral tissue pathology diagnostic criteria (oral histopathology Edition Sixth).All cases involved primary lesions without any LASER, radiation therapy or chemotherapy.

Criteria

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;

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967120

Contacts

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Contact: Zhaojun Liu, PhD	86-010-88196721	liuzhaojun@bjmu.edu.cn

Locations

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China, Beijing
Peking University Cancer Hosptial and Institute	Recruiting
Beijing, Beijing, China, 100142
Contact: Zhaojun Liu, Ph.D 86-010-88196721 liuzhaojun@bjmu.edu.cn
Contact: Dajun Deng, M.D 86-010-88196752 dengdajun@bjmu.edu.cn

Sponsors and Collaborators

Beijing Municipal Administration of Hospitals

Peking University

Investigators

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Study Director:	Dajun Deng, MD	Peking University Cancer Hosptial and Institute

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Zhaojun Liu, PhD, Beijing Municipal Administration of Hospitals
ClinicalTrials.gov Identifier:	NCT02967120
Other Study ID Numbers:	XM201303
First Posted:	November 17, 2016 Key Record Dates
Last Update Posted:	September 25, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	The number of the participants of different groups and the followup information will be shared with other researchers after the end of the study.

Additional relevant MeSH terms:

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Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms

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