Arsenic Methylation Enzymes, Cigarette Metabolites, DNA R... | NCT00854464

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

NCT00854464

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Mar 3, 2009Estimated

Enrollment

420Estimated

Phase

Not provided

Conditions

Urothelial Carcinoma

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jul 2011Estimated

Completion Date

Not provided

First Submitted Date

Mar 1, 2009

First Submission Date that Met QC Criteria

Mar 2, 2009

First Posted Date

Mar 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2009

Last Update Posted Date

Mar 3, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the relationship between arsenic methylation enzymes (AS3MT, PNP,GSTO1, and GSTO2) genetic polymorphism and UC risk.
To explore the relationship between cigarettes metabolites (NNK, NNAL, HBA, NNAL-Gluc, O6-Methylguanine, and N7-Methylguanine) and UC risk.
To examine the relationship between cigarette metabolic enzymes (CYP2A6, CYP2A13, and UGT2B7) genetic polymorphism and UC risk.
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.
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.
To examine the risk factors of the environment-environment, gene-environment, and gene-gene interaction on the risk of UC.

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:

To investigate the relationship between arsenic methylation enzymes (AS3MT, PNP, GSTO1, and GSTO2) genetic polymorphism and UC risk.
To explore the relationship between cigarettes metabolites (NNK, NNAL, HBA, NNAL-Gluc, O6-Methylguanine, and N7-Methylguanine) and UC risk.
To examine the relationship between cigarette metabolic enzymes (CYP2A6, CYP2A13, and UGT2B7) genetic polymorphism and UC risk.
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.
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.
To examine the risk factors of the environment-environment, gene-environment, and gene-gene interaction on the risk of UC.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

420Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

project recruited 420 UC patients in Taiwan University Hospital

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

project recruited 420 UC patients in Taiwan University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yeong-Shiau Pu, M.D. PhD	Contact	886-2-23123456	65249	yspu@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Yeong-Shiau Pu, M.D.PhD.	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology/National Taiwan University Hospital	Recruiting	Taipei		10002	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D002295	Carcinoma, Transitional Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided