The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at least transiently, in a fraction of patients after treatment. To investigate this hypothesis, investigators will assess the levels of CTCs both before and after treatment. The feasibility and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease|
- Effect of therapy [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients.
- Presence of baseline CTC [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]Assess for the presence of baseline CTC in bladder cancer patients with muscle-invasive or metastatic disease.
- Assessing insulin like growth factor [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]Determine the feasibility of assessing insulin like growth factor (IGF) I-R and c-Met by FISH in circulating tumor cells of patients with advanced bladder cancer.
- Correlation between CTC levels and clinical outcome [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]Evaluate for any potential correlation between CTC levels and clinical outcome
Biospecimen Retention: Samples With DNA
Serum from patients undergoing treatment for muscle-invasive or metastatic bladder cancer who are planning for surgical bladder removal or chemotherapy will be acquired.
|Study Start Date:||November 2008|
|Study Completion Date:||February 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Patients with muscle invasive or metastatic bladder cancer who will be planning for treatment with surgery or chemotherapy.
The measurement of circulating tumor cells is pursued in several cancers including breast and prostate cancer. The number of cells measured in these cancers has been shown to be prognostic. There is little information on the presence or importance of circulating tumor cells in bladder cancer. This trial is designed to determine if patients with advanced bladder cancer have circulating tumor cells and if these circulating cells are affected by treatment of the cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829920
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80010|
|Principal Investigator:||Thomas W. Flaig, MD||University of Colorado, Denver|