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

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ClinicalTrials.gov Identifier: NCT02345473
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Pagliarulo Vincenzo, Azienda Ospedaliero-Universitaria Consorziale

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.

Condition or disease Intervention/treatment
Bladder Cancer Circulating Tumor Cells Genetic: Detection of circulating tumor cells in blood samples

Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Clinical Significance of Circulating Cancer Cells in Patient Undergoing Radical Cystectomy
Study Start Date : January 2005
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Group/Cohort Intervention/treatment
Cystectomy patients
Arm of patients undergoing radical cystectomy for bladder cancer providing peripheral blood samples for detection of circulating cancer cells
Genetic: Detection 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.

Healthy volunteers
Arm of healthy subjects not undergoing radical cystectomy providing peripheral blood samples for detection of circulating cancer cells
Genetic: Detection 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Peripheral blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing radical cystectomy for bladder cancer and healthy volunteers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345473


Locations
Italy
Vincenzo Pagliarulo
Bari, Italy, 70124
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Consorziale
Investigators
Principal Investigator: Vincenzo VP Pagliarulo, Urologist Azienda Ospedaliero-Universitaria Consorziale

Publications:

Responsible Party: Pagliarulo Vincenzo, Medical Doctor, Azienda Ospedaliero-Universitaria Consorziale
ClinicalTrials.gov Identifier: NCT02345473     History of Changes
Other Study ID Numbers: 4186
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Pagliarulo Vincenzo, Azienda Ospedaliero-Universitaria Consorziale:
Bladder cancer
Circulating cancer cells

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplastic Cells, Circulating
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes