DNA Methylation and Arsenic-associated Urothelial Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01360723
First received: May 24, 2011
Last updated: May 26, 2011
Last verified: May 2011

May 24, 2011
May 26, 2011
May 2011
May 2014   (final data collection date for primary outcome measure)
urothelial carcinoma [ Time Frame: up to three years ] [ Designated as safety issue: No ]
urothelial carcinoma [ Time Frame: 2011.5-2014.5 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01360723 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
DNA Methylation and Arsenic-associated Urothelial Carcinoma
Comparison of DNA Methylation Between Urothelial Carcinoma and Healthy Controls

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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.

Urothelial Carcinoma
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
Not Provided
May 2014   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact: Chao-Hsiang Chang, PhD 886-4-22052121 ext 4439 urology8395@yahoo.com.tw
Taiwan
 
NCT01360723
DMR100-IRB-080
No
Chi-Jung Chung and Chao-Hsian Chang, Department of Urology
China Medical University Hospital
Not Provided
Principal Investigator: Chi-Jung Chung, PhD Department of Health risk Management, China Medical University
China Medical University Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP