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

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Tongue neoplasm
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Brief Title

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

Official Title

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

Brief 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.

Study Type

Observational

Primary Outcome

DNA methylation

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

300

Start Date

April 18, 2016

Primary Completion Date

April 17, 2019

Eligibility Criteria

        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.

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 886-2-23123456, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT02902406

Organization ID

201601034RINB

Responsible Party

Sponsor

Study Sponsor

National Taiwan University Hospital

Study Sponsor

, ,

Verification Date

September 2016