Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study

Oral Cancer Clinical Trial

Official title:

Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02902406
• Other study ID #: 201601034RINB
• Status: Recruiting
• Start date: April 18, 2016

Study information

• Verified date: September 2016
• Source: National Taiwan University Hospital
• Contact: Shih-Jung Cheng, PhD
• Phone: 886-2-23123456
• Email: sjcheng56[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. A prospective case control trial is designed with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all subjects will receive an intraoral examination and followed by epithelial cells collection with oral swab. The gDNA will be extracted from the oral swab collected cells and followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subject with age over 20.

• Subjects with oral mucosal findings (normal, oral mucosal lichen planus, precancerous lesion, and oral cancer) or subjects who have involved in the previous study (NCT01945697).

• Subjects agrees to sign the informed consent form.

Exclusion Criteria:

• Pregnant woman.

• Subject disagrees to sign the informed consent form.

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		2 years