Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Oral Cancer Clinical Trial

Official title:

Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945697
• Other study ID #: 201207019
• Status: Completed
• Phase: N/A
• First received: September 15, 2013
• Last updated: December 21, 2017
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer

Locations

Country	Name	City	State
Taiwan	Department of Dentistry National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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