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

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: NCT02902406
Recruitment Status : Unknown
Verified September 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 15, 2016
Last Update Posted : May 15, 2018
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease
Oral Cancer

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study
Actual Study Start Date : April 18, 2016
Estimated Primary Completion Date : April 17, 2019

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 [ Time Frame: 2 years ]

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.
  • 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.

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): NCT02902406

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Contact: Shih-Jung Cheng, PhD 886-2-23123456 ext 67509
Contact: Hsiao-Shan Lin, MD

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Department of Dentistry National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital Identifier: NCT02902406     History of Changes
Other Study ID Numbers: 201601034RINB
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: September 2016
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