Bladder Cancer Transitional Cell Carcinoma Clinical Trial
Official title:
Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology
- This study includes two semi-consecutive parts:
- Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect®
device for identifying bladder cancer cells in urine samples.
- Part II Prospective, controlled, blinded part to determine the performance of the
CellDetect® device in monitoring bladder cancer recurrence in patients with a
history of TCC, using urine cytology samples
- The following subjects will be enrolled:
Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic
surveillance, TURT or Cystectomy.
Study aim:
1. To calibrate the CellDetect® device for detecting TCC in urine cytology samples.
2. Determine the performance of the CellDetect® device in identifying TCC recurrence in
patients with a history of TCC using urine cytology samples.
The study includes two parts:
Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device
for identifying bladder cancer cells in urine samples.
Part II Prospective, controlled, blinded part to determine the performance of the
CellDetect® device in monitoring bladder cancer recurrence in in patients with a history of
TCC, using urine cytology samples
* The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer
undergoing routine cystoscopic surveillance, TURT or Cystectomy.
Part I - up to 200 urine eligible samples Part II - up to 300 urine eligible samples
Endpoints:
1. To calibrate the CellDetect® device for identifying TCC in urine cytology samples.
2. To determine the performance of the CellDetect® device in identifying recurrence of TCC
in urine samples.
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Observational Model: Cohort, Time Perspective: Prospective