NCT00867633

Brief Summary

To study the association between aristolochic acid and urothelial carcinoma in Taiwan

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Typical duration 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

March 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

First QC Date

March 22, 2009

Last Update Submit

February 20, 2012

Conditions

Keywords

urothelial carinomaaristolochic acidDNAadduct

Outcome Measures

Primary Outcomes (1)

  • the incidence of aristolochic-acid DNA adduct in the samples

    one week

Study Arms (3)

Urothelial carcinoma

The DNA samples extracted from the urothelial carcinoma tissue

RCC

the DNA sample extracted from RCC

Non-cancer

The DNA sample extracted from the non-cancerous kidney tissue

Eligibility Criteria

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

The patients who received nephrectomies

You may qualify if:

  • the resected kidney tissue in the tissue bank

You may not qualify if:

  • the patients who had been ever exposed to arsenics, rubber, chemicals, irradiation for pelvis, or received chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from the resected tissue samples

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Yeong-Shiau Pu, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Taiwan University Hospital

Study Record Dates

First Submitted

March 22, 2009

First Posted

March 24, 2009

Study Start

March 1, 2009

Study Completion

March 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations