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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari59 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bladder Cancer Circulating Tumor Cells

Interventions

Detection of circulating tumor cells in blood samplesGENETIC

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 8 years

Secondary Outcomes

Overall survival

Comparison of overall survival between the population of patients found with circulating tumor cells and those found without circulating tumor cells