DNA Methylation and Arsenic-associated Urothelial Carcinoma

Urothelial Carcinoma Clinical Trial

Official title:

Comparison of DNA Methylation Between Urothelial Carcinoma and Healthy Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01360723
• Other study ID #: DMR100-IRB-080
• Status: Recruiting
• Phase: N/A
• First received: May 24, 2011
• Last updated: May 26, 2011
• Start date: May 2011

Study information

• Verified date: May 2011
• Source: China Medical University Hospital
• Contact: Chao-Hsiang Chang, PhD
• Phone: 886-4-22052121
• Email: urology8395[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

The investigators previously pointed out the significant association between urinary arsenic profiles and urothelial carcinoma (UC) risk through a 12-year follow-up study. Further, the investigators observed the increased UC risk in people with lower plasma folate and higher homocysteine than those with higher plasma folate and lower homocysteine in 2010. S-adenosylmethionine (SAM) is one factor included in one-carbon metabolism pathway and is the main donor of methyl group in cells. The ratio of SAM and its metabolite S-adenosylhomocysteine (SAH) not only reflected the intake level of dietary folate but also demonstrated the extent of global DNA methylation. These factors might play important roles in UC carcinogenesis. The investigators would expect to take three years to explore the interactions among global DNA methylation, one-carbon metabolic pathway factors, urinary arsenic profiles, the polymorphisms and haplotype of Glycine N-methyltransferase (GNMT) and UC. In the first year, the investigators would measure the levels of plasma folate, homocysteine, SAM and SAH and evaluate the associations between these factors and UC risk. In the second year, the investigators would set up the method of immunohistochemistry stain and compare the differences between the global DNA methylation from bladder tissues and blood. In the last year, this investigators would analyze the GNMT gene polymorphism and haplotype variation. At the same time, the investigators would explore the impact of GNMT genetic variation and global DNA methylation on UC risk. Based on the results from our research, the investigators might propose that the decreased ratio of SAM/SAH resulted in UC risk increased. This mechanism might be through the changed levels of urinary arsenic profiles and global DNA methylation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of urothelial carcinoma

• The voluntary of participating the study

Exclusion Criteria:

• Age smaller than 20 years

• Pregnant women

• Not willing to participate the study because of their personal reasons

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Locations

Country	Name	City	State
Taiwan	Department of Urology, China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urothelial carcinoma		up to three years	No