- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02648789
Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Association between the DNA methylation level and the stage of cancer
Tidsramme: 1 year
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1 year
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cheng-Chieh Yang, DDS., Ph.D., Department of Stomatology, Taipei Veterans General Hospital
- Ledende efterforsker: Shou-Yen Kao, DDS., M.D.S., Department of Stomatology, Taipei Veterans General Hospital
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015-06-009AC
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