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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.
 
ClinicalTrials.gov Identifier: NCT01945697
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date September 15, 2013
First Posted Date September 18, 2013
Last Update Posted Date December 26, 2017
Study Start Date December 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2013)
DNA methylation labeled [ Time Frame: 2 years ]
To validate the association between the methylation genes and the oral cancer
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01945697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Official Title Validation of DNA Methylation Biomarkers for Oral Cancer Detection
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Cells from oral mouthwash
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.
Condition Oral Cancer
Intervention Not Provided
Study Groups/Cohorts
  • normal oral mucosa
  • oral precancerous lesion or oral cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 21, 2017)
267
Original Estimated Enrollment
 (submitted: September 15, 2013)
160
Actual Study Completion Date September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01945697
Other Study ID Numbers 201207019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Shih-Jung Cheng, MD Department of Dentistry National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date September 2014