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

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.

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Key information

Conditions

Bladder Cancer Circulating Tumor Cells Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vincenzo Pagliarulo

Bari, Italy, 70124

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Detection of circulating tumor cells in blood samples

Genetic

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.

Primary outcomes

Prevalence of circulating tumor cells

Time frame: 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 outcomes

Overall survival

Time frame: 8 years

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

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Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Acronym: CirCanCell

Important dates

Study start: 2005
Primary completion: 2014
Study completion: 2014
First posted: Jan 26, 2015
Registry last updated: Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed