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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Completed

Conditions: Bladder Cancer; Circulating Tumor Cells

Treatments: Genetic: Detection of circulating tumor cells in blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT02345473

4186

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

59 participants in 2 patient groups

Cystectomy patients

Description:

Arm of patients undergoing radical cystectomy for bladder cancer providing peripheral blood samples for detection of circulating cancer cells

Treatment:

Genetic: Detection of circulating tumor cells in blood samples

Healthy volunteers

Description:

Arm of healthy subjects not undergoing radical cystectomy providing peripheral blood samples for detection of circulating cancer cells

Treatment:

Genetic: Detection of circulating tumor cells in blood samples