Brief Title
Validation of DNA Methylation Biomarkers for Oral Cancer Detection
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 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
Primary Outcome
Association between the DNA methylation level and the stage of cancer
Condition
Oral Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
46
Start Date
May 2015
Completion Date
May 2017
Primary Completion Date
May 2017
Eligibility Criteria
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
Gender
All
Ages
20 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Cheng-Chieh Yang, DDS., Ph.D., ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT02648789
Organization ID
2015-06-009AC
Responsible Party
Sponsor
Study Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
iStat Biomedical CO., Ltd.
Study Sponsor
Cheng-Chieh Yang, DDS., Ph.D., Principal Investigator, Department of Stomatology, Taipei Veterans General Hospital
Verification Date
May 2017