Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 16, 2016
First Posted Date November 17, 2016
Last Update Posted Date September 25, 2017
Study Start Date January 2014
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2017)
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.
Original Primary Outcome Measures
 (submitted: November 16, 2016)
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 35 patients were p16-hydroxymethylation, 79 patients were p16-methylation and 222 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.
Change History Complete list of historical versions of study NCT02967120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 20, 2017)
Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation [ Time Frame: from 3 months and 36 months ]
Original Secondary Outcome Measures
 (submitted: November 16, 2016)
Overall survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation [ Time Frame: from 3 months and 36 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation
Official Title A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced;or frozen tissues;
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.
Condition Oral Epithelial Dysplasia
Intervention Other: no intervention
Study Groups/Cohorts p16 hydroxymethylation status
patients with p16 hydroxymethylation
Intervention: Other: no intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 20, 2017)
265
Original Estimated Enrollment
 (submitted: November 16, 2016)
336
Estimated Study Completion Date January 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
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;
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02967120
Other Study ID Numbers XM201303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Zhaojun Liu, Beijing Municipal Administration of Hospitals
Study Sponsor Beijing Municipal Administration of Hospitals
Collaborators Peking University
Investigators
Study Director: Dajun Deng, MD Peking University Cancer Hosptial and Institute
PRS Account Beijing Municipal Administration of Hospitals
Verification Date September 2017