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

Completed

• Conditions: Bladder Cancer; Circulating Tumor Cells
• Interventions: Genetic: Detection of circulating tumor cells in blood samples

• Registration Number: NCT02345473
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-19
• Last Update Submitted: 2015-01-19
• Study First Posted: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cystectomy patients	Detection of circulating tumor cells in blood samples	Arm of patients undergoing radical cystectomy for bladder cancer providing peripheral blood samples for detection of circulating cancer cells
Healthy volunteers	Detection of circulating tumor cells in blood samples	Arm of healthy subjects not undergoing radical cystectomy providing peripheral blood samples for detection of circulating cancer cells

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vincenzo Pagliarulo; 🇮🇹 Bari, Italy