The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease

Conditions
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Bladder Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological diagnosis of transitional cell carcinoma of the urothelium of at least T2-4, Nx, Mx stage. Mixed histologies will be allowed (e.g. squamous differentiation) as long as a transitional cell component is present. Clinical plans for surgery (with or without chemotherapy), radiation therapy, or chemotherapy. Participants must not have any condition which in the investigator's opinion may compromise the feasibility of completing the study. Subject must be 18 years of age or older Subject must be willing to have up to 4 peripheral blood samples obtained over a 6 month period of study. Prior therapies for bladder cancer will be allowed if patient currently has muscle-invasive or metastatic bladder cancer despite the previous treatments. Predicted life expectancy of > 12 weeks. Exclusion Criteria: Subjects who are unwilling or unable to comply with the study guidelines as determined by the principal investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder cancer<br>Patients with muscle invasive or metastatic bladder cancer who will be planning for treatment with surgery or chemotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of therapy | To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients. | baseline and then every 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of baseline CTC | Assess for the presence of baseline CTC in bladder cancer patients with muscle-invasive or metastatic disease. | baseline and then every 2 months | 
| Assessing insulin like growth factor | 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. | baseline and then every 2 months | 
| Correlation between CTC levels and clinical outcome | Evaluate for any potential correlation between CTC levels and clinical outcome | baseline and then every 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder cancer