Antiangiogenic Effects of BCG on Urinary Concentration of Angiogenic Factors

NCT ID: NCT00216814

Last Updated: 2008-04-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2007-09-30

Brief Summary

To determine if there is an association between basic fibroblast growth factor,vascular endothelial growth factor, and interleukin levels and a patients response to BCG treatment ( as standard treatment)in the urine of patients with superficial TCC. To determine if the levels of these angiogenic factors can predict response to BCG, disease recurrence, progression risk factors.

Detailed Description

200 patients that are candidates for intravesical BCG therapy and 20 control patients with no history of malignancy will be enrolled. The study group wol;; be asked to provide a urine sample just prior to receiving their first BCG treatment(week # 1) and just prior to receiving their last (week # 6) BCG treatment. The control patients will provide one urine sample only. Samples will be analysed by enzyme-linked immunosorbant assay(ELISA). clinical data will be reviewed on tumor stage and grade prior to BCG, timme to recurrence, tumor stage and grade of recurrence, time to disease progression and death, cause of death and total follow-up time.

Conditions

Bladder Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

200 study group 1. Must be a candidate for BCG therapy. 20 control group 1. No history of malignancy.

Exclusion Criteria

• N/A

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Principal Investigators

Jonathan Izawa, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

LHRI

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

10050E

Identifier Type: -

Identifier Source: secondary_id

R-03-275

Identifier Type: -

Identifier Source: org_study_id