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

The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.

Part A:

*Inclusion Criteria Inclusion criteria will be different for each group subjects.

Group A (Monitoring group):

1. Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance, who had normal cystoscopies for at least 12 months..
2. Ability to provide informed consent
3. Age > 18 years

Group B (Positive group):

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

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

Exclusion Criteria

1. Participation in another clinical trial within last 30 days.
2. Known pregnancy on day of screening.

Part B:

*Inclusion Criteria

Subjects meeting the following criteria (all of them) will be included in the study:

1. Subject with a documented history of TCC and who are undergoing routine cystoscopic surveillance, TURBT or cystectomy
2. At least 4 weeks have passed since any treatment for TCC (including cystoscopy and/or TURBT procedures)
3. Ability to provide informed consent

4. Age ≥ 18 years old

   • Exclusion Criteria

Subjects complying with any of the following exclusion criteria will be excluded from the study:

1. Subject with catheters, neobladder or kidney stones.
2. Subject unable to provide a spontaneous urine sample.
3. Subject currently under any cancer drug treatment.
4. No biopsy results available for subjects with positive findings on cystoscopy test, TURBT or cystectomy. [Note: such subjects will be excluded after recruitment and urine collection, as result of the delay in receiving biopsy results].
5. If more than 3 months have passed between urine sample collection and TURBT or cystectomy procedures, and no second sample was taken before undergoing TURBT, subject will be excluded from the study.
6. Subject undergoing TURBT or cystectomy whose biopsy results demonstrated abnormal findings other than TCC.
7. Subject participated in another clinical study within the last 30 days.
8. Known pregnancy on day of screening.