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Trial record 74 of 11658 for:    Oral Cancer

Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

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ClinicalTrials.gov Identifier: NCT02967120
Recruitment Status : 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

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.


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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


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



Primary Outcome Measures :
  1. 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 :
  1. 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;


Information from the National Library of Medicine

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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;

Information from the National Library of Medicine

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhaojun Liu, PhD, Beijing Municipal Administration of Hospitals
ClinicalTrials.gov Identifier: NCT02967120     History of Changes
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