Early Diagnosis of Oral Cancer by Detecting p16 Hydroxyme... | NCT02967120

Studies
Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

NCT02967120

Sponsor

Beijing Municipal Administration of Hospitals

Status

Unknown status

Last Update Posted

Sep 25, 2017Actual

Enrollment

265Estimated

Phase

Not provided

Conditions

Oral Epithelial Dysplasia

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Nov 16, 2016

First Submission Date that Met QC Criteria

Nov 16, 2016

First Posted Date

Nov 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2017

Last Update Posted Date

Sep 25, 2017Actual

Name	Class
Peking University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

265Estimated

Label	Type	Description	Intervention Names
p16 hydroxymethylation status		patients with p16 hydroxymethylation	Other: no intervention

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other		p16 hydroxymethylation status

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation		from 3 months and 36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Zhaojun Liu, PhD	Contact	86-010-88196721		liuzhaojun@bjmu.edu.cn

Name	Affiliation	Role
Dajun Deng, MD	Peking University Cancer Hosptial and Institute	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Cancer Hosptial and Institute	Recruiting	Beijing	Beijing Municipality	100142	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26137587	Background	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.
19671846	Background