Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology
18 Years
N/A
Both
Bladder Cancer Transitional Cell Carcinoma
Trial Information
Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Authority:
Israel: Ethics Commission
Study ID:
ZT-CL-04B
NCT ID:
NCT01551342
Start Date:
January 2012
Completion Date:
Related Keywords:
- Bladder Cancer Transitional Cell Carcinoma
- bladder cancer
- Transitional cell carcinoma (TCC)
- Urinary Bladder Neoplasms
- Carcinoma
- Carcinoma, Transitional Cell
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