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

NCT02345473•Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Vincenzo Pagliarulo

Bari, Italy, Italy

Key Dates

Start Date

January 1, 2005

Primary Completion Date

October 1, 2014

Completion Date

October 1, 2014

Last Updated

January 26, 2015

Enrollment

ACTUAL participants

Conditions

Bladder CancerCirculating Tumor Cells

Interventions

Detection of circulating tumor cells in blood samples

GENETIC

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

NCT03375307

Advanced Bladder CarcinomaAdvanced Genitourinary System Carcinoma+4 more

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RECRUITINGPHASE2

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

NCT07061964

Muscle Invasive Bladder Urothelial CarcinomaStage II Bladder Cancer AJCC v8+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery