Validation of DNA Methylation Biomarkers for Oral Cancer Detection

NCT02648789 | Completed DMC

• 1 other identifier: 2015-06-009AC
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Cancer; Recurrence

Keywords

Primary oral cancer; DNA methylation; Recurrence oral cancer

Outcome Measures

Primary Outcomes (1)

• Association between the DNA methylation level and the stage of cancer

  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.

  1 year

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• iStat Biomedical CO., Ltd.: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (9)

• 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.

  PMID: 18381458 BACKGROUND

• 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.

  PMID: 16434596 BACKGROUND

• 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.

  PMID: 17097722 BACKGROUND

• 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.

  PMID: 22645611 BACKGROUND

• 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.

  PMID: 22359295 BACKGROUND

• 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.

  PMID: 22252571 BACKGROUND

• 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.

  PMID: 16763272 BACKGROUND

• 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.

  PMID: 18235120 BACKGROUND

• 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.

  PMID: 23907469 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

oral swab, non-cancerous matched tissue and tumor tissue

MeSH Terms

Conditions

Mouth Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: January 7, 2016
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 9, 2018

Record last verified: 2017-05

Locations

TW (1)