NCT01378052

Brief Summary

Many studies previously showed the significant association between urinary arsenic profiles and urothelial carcinoma (UC) risk and observed the increased UC risk in people with lower plasma folate and higher homocysteine than those with higher plasma folate and lower homocysteine. The investigators would expect to explore the interactions among global DNA methylation, one-carbon metabolic pathway factors, urinary arsenic profiles and UC.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

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

June 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

June 20, 2011

Last Update Submit

June 21, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Study Arms (2)

urothelial carcinoma pateints

healthy controls

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 Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a hospital-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 recruited including those receiving adult health examinations at China Medical University Hospital.

You may qualify if:

  • Clinical diagnosis of urothelial carcinoma
  • The voluntary of participating the study

You may not qualify if:

  • Age smaller than 20 years
  • Pregnant women
  • Not willing to participate the study because of their personal reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Chi-Jung Chung, PhD

    Department of Health risk Management, China Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Hsiang Chang, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 20, 2011

First Posted

June 22, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations