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Validation of DNA Methylation Biomarkers for Oral Cancer Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01945697
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : December 26, 2017
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease
Oral Cancer

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Study Type : Observational
Actual Enrollment : 267 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Study Start Date : December 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

normal oral mucosa
oral precancerous lesion or oral cancer

Primary Outcome Measures :
  1. DNA methylation labeled [ Time Frame: 2 years ]
    To validate the association between the methylation genes and the oral cancer

Biospecimen Retention:   Samples With DNA
Cells from oral mouthwash

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients come to the Department of Dentistry of National Taiwan University Hospital for oral health care or treatment.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01945697

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Department of Dentistry National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Shih-Jung Cheng, MD Department of Dentistry National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital Identifier: NCT01945697    
Other Study ID Numbers: 201207019
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: September 2014
Keywords provided by National Taiwan University Hospital:
DNA methylation, biomarkers, oral cancer
Additional relevant MeSH terms:
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Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Lip Diseases