Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Recurrence Clinical Trial

Official title:

Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648789
• Other study ID #: 2015-06-009AC
• Status: Completed
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer
• Recurrence

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	iStat Biomedical CO., Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (9)

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. — View Citation

Fakhry C, Gillison ML. Clinical implications of human papillomavirus in head and neck cancers. J Clin Oncol. 2006 Jun 10;24(17):2606-11. Review. — View Citation

García MP, García-García 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. Review. — View Citation

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. — View Citation

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. Epub 2006 Nov 13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between the DNA methylation level and the stage of cancer	Compare the DNA methylation level and the stage of cancer before treatment.; DNA methylation level as a monitor tool for recurrence/metastasis of oral cancer.; qPCR will be used to determine the DNA methylation level.	1 year