Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology

• The study includes two parts: Open label calibration part and prospective blinded part to determine the feasibility of CellDetect® device to identify bladder cancer in urine cytology samples.

• The following subjects will be enrolled:

  • Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance
  • Subjects undergoing TURTor Cystectomy procedures

Study aim:

1. Calibrate the CellDetect® device for detecting bladder cancer (TCC) in urine cytology samples.
2. Determine the feasibility of CellDetect® device to detect bladder cancer in urine cytology samples.

The study includes two parts: Open label calibration part and prospective blinded part to determine the feasibility of CellDetect® device to identify bladder cancer in urine cytology samples.

* The following subjects will be enrolled:

• Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance
• Subjects undergoing TURTor Cystectomy procedures

Part I - up to 100 urine eligible samples Part II - up to 200 urine eligible samples

Endpoints:

1. Calibrate the CellDetect® device for identifying TCC in urine cytology.
2. Show reproducibility and performance of the calibrated product in urine cytology samples.
3. Provide preliminary data showing the feasibility of CellDetect® device to correctly identify TCC in urine samples.

The following subjects will be enrolled: Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance.

Subjects undergoing TURTor Cystectomy procedures

• routine cystoscopic surveillance
  Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance
• TURT or Cystectomy procedures
  Subjects undergoing TURT or Cystectomy procedures

Inclusion Criteria:

Inclusion criteria will be different for each group subjects.

Group A:

1. Subjects diagnosed with bladder cancer and have no history of disease recurrence for over 12 month from last treatment and are undergoing routine cystoscopic surveillance.
2. Ability to provide informed consent
3. Age > 18 years

Group B:

1. Subject undergoing TURT or cystectomy due to any of the following reasons:

   • Subjects with suspected or known bladder cancer (hematuria subjects)
   • Subjects with previously diagnosed bladder cancer undergoing routine cystoscopic surveillance.
2. Ability to provide informed consent
3. Age > 18 years

Exclusion Criteria:

1. Subject currently under other cancer drug treatment or subject completed cancer drug treatment less than 4 weeks prior to study screening.
2. Participation in another clinical trial within last 30 days.
3. Known pregnancy on day of screening.