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Trial record 11 of 172 for:    "Lip and oral cavity cancer"

Validation of DNA Methylation Biomarkers for Oral Cancer Detection

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ClinicalTrials.gov Identifier: NCT02648789
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
iStat Biomedical CO., Ltd.
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
The purpose of this study is to investigate the correlation between DNA methylation and the treatment and recurrence of oral cancer.

Condition or disease
Oral Cancer Recurrence

Detailed Description:

In this study, investigators plan to recruit 40~50 patients who had, or currently has oral cancer. The study procedures are as below:

  • After the Informed Consent Form is signed, swab from the lesion site and normal site to obtain oral epithelial cells.
  • Collect tissue from the tumor site and the non-cancerous matched site from the surgery or the tissue bank.
  • Collect oral swab from the lesion site and the normal site when patients return to the clinic for a regular follow-up.

Specimens will be collected for DNA methylation testing, and the results will be compared with patient's clinical diagnosis. It is expected that the relationship between DNA methylation, oral cancer, and the recurrence of oral cancer will be found.


Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Actual Study Start Date : May 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer




Primary Outcome Measures :
  1. Association between the DNA methylation level and the stage of cancer [ Time Frame: 1 year ]
    1. Compare the DNA methylation level and the stage of cancer before treatment.
    2. DNA methylation level as a monitor tool for recurrence/metastasis of oral cancer.
    3. qPCR will be used to determine the DNA methylation level.


Biospecimen Retention:   Samples With DNA
oral swab, non-cancerous matched tissue and tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Investigators plan to retrieve the tissue from the biobank in Taipei Veterans General Hospital or recruit oral cancer patients in this study over six months. The total patient number are 40-50. Specimen types include non-cancerous matched tissues, cancer tissues, and the oral swab. DNA methylation for several genes will be tested by using standardized reagents and instruments.
Criteria

Inclusion Criteria:

  • Age between 20 and 75 years old
  • Had or currently has cancer of the oral cavity
  • Agree to sign the Informed Consent Form (ICF) and comply with follow-up procedures

Exclusion Criteria:

  • Unwilling to sign the Informed Consent Form (ICF)
  • Has an autoimmune disease of the oral cavity

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 ClinicalTrials.gov identifier (NCT number): NCT02648789


Locations
Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
iStat Biomedical CO., Ltd.
Investigators
Principal Investigator: Cheng-Chieh Yang, DDS., Ph.D. Department of Stomatology, Taipei Veterans General Hospital
Principal Investigator: Shou-Yen Kao, DDS., M.D.S. Department of Stomatology, Taipei Veterans General Hospital

Publications:

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02648789     History of Changes
Other Study ID Numbers: 2015-06-009AC
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: May 2017

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Primary oral cancer
DNA methylation
Recurrence oral cancer

Additional relevant MeSH terms:
Recurrence
Mouth Neoplasms
Lip Neoplasms
Disease Attributes
Pathologic Processes
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases