Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01945697

Enrollment

267

Registered

2013-09-18

Start date

2012-12-31

Completion date

2014-09-30

Last updated

2017-12-26

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

Conditions

Oral Cancer

Keywords

DNA methylation, biomarkers, oral cancer

Brief summary

The aim of this study is to evaluate the association between several methylated genes and oral cancers. A prospective case control trial is designed with sample size estimated at least 160 cases. It is expected to enroll at least 100 subjects with precancerous lesion or oral cancer, and \ 60 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all of the subjects will receive an intraoral examination and the oral epithelial cells will be collected. If abnormal oral lesion is observed, it will be photographed, and the biopsy will be performed to confirm the diagnosis. For methylated gene detections, the gDNA will be extracted from the collected cells and standardized assay will be performed. Clinical sensitivity and specificity for these methylated genes will be evaluated.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subject with age over 20. * Subject agrees to sign the informed consent form.

Exclusion criteria

* Subjects have history of head and neck cancer. * Subjects have had received chemotherapy for cancers. * Pregnant Woman * Subjects whose has oral mucosal lichen planus. * Subjects whose oral mucosal findings is abnormal, but the diagnosis is unknown.

Design outcomes

Primary

Measure	Time frame	Description
DNA methylation labeled	2 years	To validate the association between the methylation genes and the oral cancer

Countries

Taiwan

Outcome results