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Antiangiogenic Effects of BCG on Urinary Concentration of Angiogenic Factors

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ClinicalTrials.gov Identifier: NCT00216814
Recruitment Status : Terminated (No funding and data was not appropriate to consider continuing.)
First Posted : September 22, 2005
Last Update Posted : April 22, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Bladder Cancer

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.

Study Design

Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intravesically Administered BCG May Have Antiangiogenic Effects on Urinary Concentrations of Basic Fibroblast Growth Factor ( bFGF), Vascular Endothelial Growth Factor (VEGF) and Interleukin (IL-8)
Study Start Date : October 2003
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with bladder cancer that are receiving treatment with BCG.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216814


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Jonathan Izawa, MD, FRCSC LHRI
More Information

ClinicalTrials.gov Identifier: NCT00216814     History of Changes
Other Study ID Numbers: R-03-275
10050E
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: January 2008

Keywords provided by Lawson Health Research Institute:
antiangiogenic effects of bcg treatment and prognosis

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Endothelial Growth Factors
Angiogenesis Inhibitors
Growth Substances
Physiological Effects of Drugs
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents