Validation of DNA Methylation Biomarkers for Oral Cancer Detection

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Tongue neoplasm
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Brief Title

Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Official Title

Validation of DNA Methylation Biomarkers for Oral Cancer Detection

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.

Study Type

Observational

Primary Outcome

DNA methylation labeled

Condition

Oral Cancer

Study Arms / Comparison Groups

 normal oral mucosa
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

267

Start Date

December 2012

Completion Date

September 2014

Primary Completion Date

September 2014

Eligibility Criteria

        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.

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Shih-Jung Cheng, MD, ,

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT01945697

Organization ID

201207019

Responsible Party

Sponsor

Study Sponsor

National Taiwan University Hospital

Study Sponsor

Shih-Jung Cheng, MD, Principal Investigator, Department of Dentistry National Taiwan University Hospital

Verification Date

September 2014