Validation of DNA Methylation Biomarkers for Oral Cancer Detection
NCT ID: NCT02648789
Last Updated: 2018-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2015-05-31
2017-05-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Has an autoimmune disease of the oral cavity
20 Years
75 Years
ALL
No
Sponsors
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iStat Biomedical CO., Ltd.
INDUSTRY
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Principal Investigators
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Cheng-Chieh Yang, DDS., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Stomatology, Taipei Veterans General Hospital
Shou-Yen Kao, DDS., M.D.S.
Role: PRINCIPAL_INVESTIGATOR
Department of Stomatology, Taipei Veterans General Hospital
Locations
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Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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Wang SS, Smiraglia DJ, Wu YZ, Ghosh S, Rader JS, Cho KR, Bonfiglio TA, Nayar R, Plass C, Sherman ME. Identification of novel methylation markers in cervical cancer using restriction landmark genomic scanning. Cancer Res. 2008 Apr 1;68(7):2489-97. doi: 10.1158/0008-5472.CAN-07-3194.
Sova P, Feng Q, Geiss G, Wood T, Strauss R, Rudolf V, Lieber A, Kiviat N. Discovery of novel methylation biomarkers in cervical carcinoma by global demethylation and microarray analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):114-23. doi: 10.1158/1055-9965.EPI-05-0323.
Lai HC, Lin YW, Chang CC, Wang HC, Chu TW, Yu MH, Chu TY. Hypermethylation of two consecutive tumor suppressor genes, BLU and RASSF1A, located at 3p21.3 in cervical neoplasias. Gynecol Oncol. 2007 Mar;104(3):629-35. doi: 10.1016/j.ygyno.2006.10.003. Epub 2006 Nov 13.
Towle R, Garnis C. Methylation-mediated molecular dysregulation in clinical oral malignancy. J Oncol. 2012;2012:170172. doi: 10.1155/2012/170172. Epub 2012 May 7.
Garcia MP, Garcia-Garcia A. Epigenome and DNA methylation in oral squamous cell carcinoma. Methods Mol Biol. 2012;863:207-19. doi: 10.1007/978-1-61779-612-8_12.
Nagata S, Hamada T, Yamada N, Yokoyama S, Kitamoto S, Kanmura Y, Nomura M, Kamikawa Y, Yonezawa S, Sugihara K. Aberrant DNA methylation of tumor-related genes in oral rinse: a noninvasive method for detection of oral squamous cell carcinoma. Cancer. 2012 Sep 1;118(17):4298-308. doi: 10.1002/cncr.27417. Epub 2012 Jan 17.
Fakhry C, Gillison ML. Clinical implications of human papillomavirus in head and neck cancers. J Clin Oncol. 2006 Jun 10;24(17):2606-11. doi: 10.1200/JCO.2006.06.1291.
Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and -unrelated oral squamous cell carcinomas in the United States. J Clin Oncol. 2008 Feb 1;26(4):612-9. doi: 10.1200/JCO.2007.14.1713.
Huang YK, Peng BY, Wu CY, Su CT, Wang HC, Lai HC. DNA methylation of PAX1 as a biomarker for oral squamous cell carcinoma. Clin Oral Investig. 2014 Apr;18(3):801-8. doi: 10.1007/s00784-013-1048-6. Epub 2013 Aug 2.
Other Identifiers
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2015-06-009AC
Identifier Type: -
Identifier Source: org_study_id
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