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Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Completed
Conditions
Recurrence
Oral Cancer
Registration Number
NCT02648789
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
46
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Association between the DNA methylation level and the stage of cancer1 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Taipei Veterans General Hospital

🇨🇳

Taipei, Taiwan

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