Validation of DNA Methylation Biomarkers for Oral Cancer Detection

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01945697
First received: September 15, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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
Oral Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • DNA methylation labeled [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To validate the association between the methylation genes and the oral cancer


Biospecimen Retention:   Samples With DNA

Cells from oral mouthwash


Estimated Enrollment: 160
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
normal oral mucosa
oral precancerous lesion or oral cancer

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945697

Contacts
Contact: Shih-Jung Cheng, MD 02-23123456 ext 67509 sjcheng56@ntu.edu.tw
Contact: Meng-Tsen Han, BS erica@istat.com.tw

Locations
Taiwan
Department of Dentistry National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shih-Jung Cheng, MD Department of Dentistry National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01945697     History of Changes
Other Study ID Numbers: 201207019
Study First Received: September 15, 2013
Last Updated: April 14, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
DNA methylation, biomarkers, oral cancer

Additional relevant MeSH terms:
Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases

ClinicalTrials.gov processed this record on July 28, 2014