Validation of DNA Methylation Biomarkers for Oral Cancer Detection

NCT01945697 | Completed DMC

• 1 other identifier: 201207019
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer

Keywords

DNA methylation, biomarkers, oral cancer

Outcome Measures

Primary Outcomes (1)

• DNA methylation labeled

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

  2 years

Study Arms (2)

normal oral mucosa

oral precancerous lesion or oral cancer

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject with age over 20.
• Subject agrees to sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Dentistry National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cells from oral mouthwash

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Shih-Jung Cheng, MD

  Department of Dentistry National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2013
• First Posted: September 18, 2013
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 26, 2017

Record last verified: 2014-09

Locations

TW (1)