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Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02648789
Enrollment
46
Registered
2016-01-07
Start date
2015-05-31
Completion date
2017-05-31
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer, Recurrence

Keywords

Primary oral cancer, DNA methylation, Recurrence oral cancer

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.

Interventions

None listed

Sponsors

iStat Biomedical CO., Ltd.
CollaboratorINDUSTRY
Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Association between the DNA methylation level and the stage of cancer1 year1. 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026