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Completed

NCT Number: NCT02648789

Validation of DNA Methylation Biomarkers for Oral Cancer Detection

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

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Key information

Conditions

Oral Cancer Disease Attributes Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Stomatognathic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Association between the DNA methylation level and the stage of cancer

    Time frame: 1 year

    • Compare the DNA methylation level and the stage of cancer before treatment.
    • DNA methylation level as a monitor tool for recurrence/metastasis of oral cancer.
    • qPCR will be used to determine the DNA methylation level.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Collaborators

  • iStat Biomedical CO., Ltd.

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 7, 2016
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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