Detection and Clinical Significance of Circulating Cancer Cells in Patient Undergoing Radical Cystectomy

Study Overview
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Brief Summary
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Very few factors may be identified as prognostic for patients with bladder cancer undergoing radical cystectomy. Recently, detection of circulating tumor cells has shown to be very promising in anticipating both the likelyhood of distant metastases and survival in patients with breast cancer, melanoma, prostate cancer and other malignancies. In the present study we both tested the detection rate of circulating tumor cells using a PCR based methodology in the peripheral blood of patients undergoing radical cystectomy, and we further correlated our results with their clinical outcome.

Official Title
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Detection and Clinical Significance of Circulating Cancer Cells in Patient Undergoing Radical Cystectomy

Conditions
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Bladder Cancer, Circulating Tumor Cells

Intervention / Treatment
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* Genetic: Detection of circulating tumor cells in blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior trans urethral resection of the bladder (TUR) Histological confirmation of a transitional cell carcinoma (TCC) of the bladder ECOG Performance Status ≤ 2 WBC count ≥4,000/μL; platelet count ≥150,000/μL; creatinine ≤1.8 mg/dL; AST, ALT, and alkaline phosphatase ≤2X the upper limit of normal, normal total bilirubin recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC Exclusion Criteria: Neo-adjuvant chemotherapy (either planned or already performed) Patients receiving investigational medications Subjects not suitable for a radical cystectomy Patients not willing to participate

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cystectomy patients<br>Arm of patients undergoing radical cystectomy for bladder cancer providing peripheral blood samples for detection of circulating cancer cells | Genetic: Detection of circulating tumor cells in blood samples<br>* Ficoll based isolation of mononuclear cells from the peripheral blood of patients undergoing radical cystectomy, nucleic acids extraction and, finally, PCR based detection of sequences specific to cytokeratins.<br>|
| Healthy volunteers<br>Arm of healthy subjects not undergoing radical cystectomy providing peripheral blood samples for detection of circulating cancer cells | Genetic: Detection of circulating tumor cells in blood samples<br>* Ficoll based isolation of mononuclear cells from the peripheral blood of patients undergoing radical cystectomy, nucleic acids extraction and, finally, PCR based detection of sequences specific to cytokeratins.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of circulating tumor cells | This outcome measure reflects the exact number of subjects diagnosed with circulating tumor cells within the total population of subjects included in the study | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Comparison of overall survival between the population of patients found with circulating tumor cells and those found without circulating tumor cells | 8 years | 

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