Antiangiogenic Effects of BCG on Urinary Concentration of Angiogenic Factors

NCT ID: NCT00216814

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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

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Bladder Cancer

Keywords

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antiangiogenic effects of bcg treatment and prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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

OTHER

Sponsor Role lead

Principal Investigators

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Jonathan Izawa, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

LHRI

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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10050E

Identifier Type: -

Identifier Source: secondary_id

R-03-275

Identifier Type: -

Identifier Source: org_study_id