Validation of DNA Methylation Biomarkers for Oral Cancer Detection

August 7, 2018 updated by: Taipei Veterans General Hospital, Taiwan
The purpose of this study is to investigate the correlation between DNA methylation and the treatment and recurrence of oral cancer.

Study Overview

Status

Completed

Conditions

Detailed Description

In this study, investigators plan to recruit 40~50 patients who had, or currently has oral cancer. The study procedures are as below:

  • After the Informed Consent Form is signed, swab from the lesion site and normal site to obtain oral epithelial cells.
  • Collect tissue from the tumor site and the non-cancerous matched site from the surgery or the tissue bank.
  • Collect oral swab from the lesion site and the normal site when patients return to the clinic for a regular follow-up.

Specimens will be collected for DNA methylation testing, and the results will be compared with patient's clinical diagnosis. It is expected that the relationship between DNA methylation, oral cancer, and the recurrence of oral cancer will be found.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Investigators plan to retrieve the tissue from the biobank in Taipei Veterans General Hospital or recruit oral cancer patients in this study over six months. The total patient number are 40-50. Specimen types include non-cancerous matched tissues, cancer tissues, and the oral swab. DNA methylation for several genes will be tested by using standardized reagents and instruments.

Description

Inclusion Criteria:

  • Age between 20 and 75 years old
  • Had or currently has cancer of the oral cavity
  • Agree to sign the Informed Consent Form (ICF) and comply with follow-up procedures

Exclusion Criteria:

  • Unwilling to sign the Informed Consent Form (ICF)
  • Has an autoimmune disease of the oral cavity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between the DNA methylation level and the stage of cancer
Time Frame: 1 year
  1. Compare the DNA methylation level and the stage of cancer before treatment.
  2. DNA methylation level as a monitor tool for recurrence/metastasis of oral cancer.
  3. qPCR will be used to determine the DNA methylation level.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

iStat Biomedical CO., Ltd.

Investigators

  • Principal Investigator: Cheng-Chieh Yang, DDS., Ph.D., Department of Stomatology, Taipei Veterans General Hospital
  • Principal Investigator: Shou-Yen Kao, DDS., M.D.S., Department of Stomatology, Taipei Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-06-009AC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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