Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

NCT02967120 | Unknown DMC

• 1 other identifier: XM201303
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Epithelial Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation

  from 3 months and 36 months

Study Arms (1)

p16 hydroxymethylation status

patients with p16 hydroxymethylation

Other: no intervention

Interventions

no intervention OTHER

p16 hydroxymethylation status

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Municipal Administration of Hospitals: lead
• Peking University: collaborator

Study Sites (1)

Peking University Cancer Hosptial and Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 26137587 BACKGROUND

• 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.

  PMID: 19671846 BACKGROUND

• 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.

  PMID: 30249192 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

• Dajun Deng, MD

  Peking University Cancer Hosptial and Institute

  STUDY DIRECTOR

Central Study Contacts

Zhaojun Liu, PhD

CONTACT

86-010-88196721; liuzhaojun@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 17, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)