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
  Purpose

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.


Condition
Urothelial Carcinoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comparison of DNA Methylation Between Urothelial Carcinoma and Healthy Controls

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • urothelial carcinoma [ Time Frame: up to three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: May 2011
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360723

Contacts
Contact: Chao-Hsiang Chang, PhD 886-4-22052121 ext 4439 urology8395@yahoo.com.tw

Locations
Taiwan
Department of Urology, China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Chao-Hsiang Chuang, PhD    886-4-22052121 ext 4439    urology8395@yahoo.com.tw   
Principal Investigator: Chi-Jung Chung, PhD         
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Chi-Jung Chung, PhD Department of Health risk Management, China Medical University
  More Information

No publications provided

Responsible Party: Chi-Jung Chung and Chao-Hsian Chang, Department of Urology
ClinicalTrials.gov Identifier: NCT01360723     History of Changes
Other Study ID Numbers: DMR100-IRB-080
Study First Received: May 24, 2011
Last Updated: May 26, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 19, 2014