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Completed

NCT Number: NCT01945697

Validation of DNA Methylation Biomarkers for Oral Cancer Detection

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.

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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dentistry National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. DNA methylation labeled

    Time frame: 2 years

    To validate the association between the methylation genes and the oral cancer

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 18, 2013
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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