Bladder Cancer, Circulating Tumor Cells
Conditions
Keywords
Bladder cancer, Circulating cancer cells
Brief summary
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.
Interventions
GENETICDetection of circulating tumor cells in blood samples
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.
Sponsors
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of circulating tumor cells | 8 years | This outcome measure reflects the exact number of subjects diagnosed with circulating tumor cells within the total population of subjects included in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 8 years | Comparison of overall survival between the population of patients found with circulating tumor cells and those found without circulating tumor cells |
Countries
Italy
Outcome results
None listed