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NCT02902406

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

Status unknown Last updated 15 May 2018
What this trial tests

trial in Oral Cancer in 300 participants. Status unknown.

Timeline
18 April 2016
Primary endpoint
17 April 2019

Quick facts

Lead sponsorNational Taiwan University Hospital
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment300
Start date18 April 2016
Primary completion17 April 2019
Sites1 location across Taiwan

Conditions studied

Sponsor

National Taiwan University Hospital

Who can join

20 and older, any sex, with Oral Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Oral Cancer

Currently open trials in the same condition.

Other National Taiwan University Hospital trials

Trials by the same sponsor.

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Data sources for this page

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