DNA Methylation and Arsenic-associated Urothelial Carcinoma

NCT01360723 | Unknown

• 1 other identifier: DMR100-IRB-080
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• urothelial carcinoma

  up to three years

Study Arms (2)

urothelial carcinoma

Pathological verification of UC was done by routine urological practice including endoscopic biopsy or surgical resection of urinary tract tumors followed by histopathological examination by board-certified pathologists.

Healthy controls group

Age and gender matched control subjects with no evidence of UC or any other malignancy were accrued from the hospital, recruiting people receiving adult health examinations at China Medical University Hospital.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a hosital-based case-control study. Patients with urothelial carcinoma are recruited by pathological verification of UC was done by routine urological practice including endoscopic biopsy or surgical resection of urinary tract tumors followed by histopathological examination by board-certified pathologists. Healthy controls without evidence of UC or any other malignancy were recurited including those receiving adult health examinations at China Medical University Hospital.

You may qualify if:

• Clinical diagnosis of urothelial carcinoma
• The voluntary of participating the study

You may not qualify if:

• Age smaller than 20 years
• Pregnant women
• Not willing to participate the study because of their personal reasons

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Department of Urology, China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Chi-Jung Chung, PhD

  Department of Health risk Management, China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Hsiang Chang, PhD

CONTACT

886-4-22052121; urology8395@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 26, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2014
• Last Updated: May 27, 2011

Record last verified: 2011-05

Locations

TW (1)