Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology
Study Details
Study Description
Brief Summary
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This study includes two semi-consecutive parts:
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Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples.
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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
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The following subjects will be enrolled:
Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Study aim:
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To calibrate the CellDetect® device for detecting TCC in urine cytology samples.
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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:
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To calibrate the CellDetect® device for identifying TCC in urine cytology samples.
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To determine the performance of the CellDetect® device in identifying recurrence of TCC in urine samples.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Cystoscopic surveillance, TURT or Cystectomy The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy. |
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Part A:
*Inclusion Criteria Inclusion criteria will be different for each group subjects.
Group A (Monitoring group):
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Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance, who had normal cystoscopies for at least 12 months..
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Ability to provide informed consent
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Age > 18 years
Group B (Positive group):
- Subject undergoing TURT or cystectomy due to any of the following reasons:
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Subjects with suspected or known TCC (hematuria subjects)
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Subjects with previously diagnosed TCC undergoing routine cystoscopic surveillance.
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Ability to provide informed consent
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Age > 18 years
Exclusion Criteria
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Participation in another clinical trial within last 30 days.
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Known pregnancy on day of screening.
Part B:
*Inclusion Criteria
Subjects meeting the following criteria (all of them) will be included in the study:
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Subject with a documented history of TCC and who are undergoing routine cystoscopic surveillance, TURBT or cystectomy
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At least 4 weeks have passed since any treatment for TCC (including cystoscopy and/or TURBT procedures)
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Ability to provide informed consent
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Age ≥ 18 years old
- Exclusion Criteria
Subjects complying with any of the following exclusion criteria will be excluded from the study:
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Subject with catheters, neobladder or kidney stones.
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Subject unable to provide a spontaneous urine sample.
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Subject currently under any cancer drug treatment.
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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].
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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.
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Subject undergoing TURBT or cystectomy whose biopsy results demonstrated abnormal findings other than TCC.
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Subject participated in another clinical study within the last 30 days.
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Known pregnancy on day of screening.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Emek Medical Center | Afula | Israel | ||
2 | Urology Department, Bnai Zion Medical Center | Haifa | Israel | ||
3 | Urology Department, Hadassah Medical Center Ein Kerem | Jerusalem | Israel | ||
4 | Urology Department, Meir Medical Center | Kfar Sava | Israel | ||
5 | Urology Department, Rabin Medical Center, Belinson Campus | Petach Tikva | Israel | ||
6 | Urology Department, Sourasky Medical Center | Tel Aviv | Israel | ||
7 | Urology Department, Sheba Medical Center | Tel Hashomer | Israel |
Sponsors and Collaborators
- Zetiq Technologies
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZT-CL-04B