NCT00854464

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

March 3, 2009

Status Verified

March 1, 2009

Enrollment Period

2.9 years

First QC Date

March 1, 2009

Last Update Submit

March 2, 2009

Conditions

Urothelial Carcinoma

Keywords

Arsenic Methylation CapabilityArsenic Methylation EnzymesCigarette MetabolitesCigarette Metabolic EnzymesDNA Repair EnzymesInflammatory FactorsUrothelial Carcinoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

project recruited 420 UC patients in Taiwan University Hospital

You may qualify if:

  • project recruited 420 UC patients in Taiwan University Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology/National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Yeong-Shiau Pu, M.D.PhD.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeong-Shiau Pu, M.D. PhD

CONTACT

886-2-23123456yspu@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2009

First Posted

March 3, 2009

Study Start

August 1, 2008

Primary Completion

July 1, 2011

Last Updated

March 3, 2009

Record last verified: 2009-03

Locations

TW(1)