Antiangiogenic Effects of BCG on Urinary Concentration of Angiogenic Factors

This study has been terminated.
(No funding and data was not appropriate to consider continuing.)
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00216814
First received: September 19, 2005
Last updated: April 18, 2008
Last verified: January 2008
  Purpose

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
Bladder Cancer

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Enrollment: 220
Study Start Date: October 2003
Study Completion Date: September 2007
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.

  Eligibility

Genders Eligible for Study:   Both
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:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00216814     History of Changes
Other Study ID Numbers: R-03-275, 10050E
Study First Received: September 19, 2005
Last Updated: April 18, 2008
Health Authority: Canada: Health Canada

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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014