Clinical Trial: Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Brief Summary: The purpose of this study is to investigate the correlation between DNA methylation and the treatment and recurrence of oral cancer.

Detailed Summary:

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.


Sponsor: Taipei Veterans General Hospital, Taiwan

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Taipei Veterans General Hospital, Taiwan

Dates:
Date Received: September 15, 2013
Date Started: December 2012
Date Completion: May 2016
Last Updated: January 5, 2016
Last Verified: January 2016