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Arsenic Methylation Enzymes, Cigarette Metabolites, DNA Repair Enzymes, Inflammatory Factors and Urothelial Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00854464
First received: March 1, 2009
Last updated: March 2, 2009
Last verified: March 2009
History of Changes
  Purpose
  1. To investigate the relationship between arsenic methylation enzymes (AS3MT, PNP,GSTO1, and GSTO2) genetic polymorphism and UC risk.
  2. To explore the relationship between cigarettes metabolites (NNK, NNAL, HBA, NNAL-Gluc, O6-Methylguanine, and N7-Methylguanine) and UC risk.
  3. To examine the relationship between cigarette metabolic enzymes (CYP2A6, CYP2A13, and UGT2B7) genetic polymorphism and UC risk.
  4. To elucidate the relationship between DNA repair enzymes (MGMT, XPD, XRCC1, and XRCC3) gene polymorphism and 8-OHdG or between DNA repair enzymes and UC risk.
  5. To examine relationship between COX-2 (-1195G/A、-765G/C 和8473C/T), IL-6, IL-8, and TNF-α gene polymorphism and 8-OHdG or between COX-2, IL-6, IL-8, and TNF-α gene polymorphism and UC risk.
  6. To examine the risk factors of the environment-environment, gene-environment, and gene-gene interaction on the risk of UC.

Condition
Urothelial Carcinoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Arsenic Methylation, Cigarette Smoking Exposure, Individual DNA Susceptibility Factors and Urothelial Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 420
Study Start Date: August 2008
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Urothelial carcinoma (UC) arises exclusively from the urothelium including the renal pelvis,ureter, bladder and urethra, with bladder transitional cell carcinoma (TCC) being the most common form. Arsenic is a well-established human carcinogen of the skin and lung. Recent studies have well documented that the long-term exposure to inorganic arsenic through ingestion and inhalation is associated with an increased risk of bladder cancer, especially TCC.

However, the carcinogenic mechanism of arsenic-induced UC is still unclear. Recently our study found that cigarette smoking interacts with the urinary arsenic profile in modifying the UC risk. In addition, we also found that DNA damage marker 8-hydroxydeoxyguanine (8-OHdG) levels significantly higher in UC patients compared to healthy controls. The mechanism of the interaction between arsenic methylation and cigarette on UC risk is unknown. In addition, whether 8-OHdG is related to DNA repair enzymes or to inflammatory factors or not does need to explore, therefore the specific aims of this project are:

  1. To investigate the relationship between arsenic methylation enzymes (AS3MT, PNP, GSTO1, and GSTO2) genetic polymorphism and UC risk.
  2. To explore the relationship between cigarettes metabolites (NNK, NNAL, HBA, NNAL-Gluc, O6-Methylguanine, and N7-Methylguanine) and UC risk.
  3. To examine the relationship between cigarette metabolic enzymes (CYP2A6, CYP2A13, and UGT2B7) genetic polymorphism and UC risk.
  4. To elucidate the relationship between DNA repair enzymes (MGMT, XPD, XRCC1, and XRCC3) gene polymorphism and 8-OHdG or between DNA repair enzymes and UC risk.
  5. To examine relationship between COX-2 (-1195G/A、-765G/C 和8473C/T), IL-6, IL-8, and TNF-α gene polymorphism and 8-OHdG or between COX-2, IL-6, IL-8, and TNF-α gene polymorphism and UC risk.
  6. To examine the risk factors of the environment-environment, gene-environment, and gene-gene interaction on the risk of UC.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

project recruited 420 UC patients in Taiwan University Hospital

Criteria

Inclusion Criteria:

  • project recruited 420 UC patients in Taiwan University Hospital

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854464

Contacts
Contact: Yeong-Shiau Pu, M.D. PhD 886-2-23123456 ext 65249 yspu@ntu.edu.tw

Locations
Taiwan
Department of Urology/National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yeong-Shiau Pu, M.D.PhD. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Yeong-Shiau Pu, Department of Urology / National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00854464     History of Changes
Other Study ID Numbers: 200809019R
Study First Received: March 1, 2009
Last Updated: March 2, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Arsenic Methylation Capability
Arsenic Methylation Enzymes
Cigarette Metabolites
Cigarette Metabolic Enzymes
 DNA Repair Enzymes
Inflammatory Factors
Urothelial Carcinoma

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

ClinicalTrials.gov processed this record on September 26, 2012