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Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder EpiCheck | Experimental | Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology |
|
| Practice of medicine | No Intervention | Practice of medicine including cystoscopy and cytology |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder EpiCheck | Other | Urine test for the monitoring of bladder cancer recurrence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity (the proportion of positives that are correctly identified as such by the gold standard) | the proportion of positives that are correctly identified as such by the gold standard | Day 1 |
| Specificity (the proportion of negatives that are correctly identified as such by the gold standard) | the proportion of negatives that are correctly identified as such by the gold standard | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shmulik Adler | Nucleix Ltd. | Study Director |
| Fred Witjes, Prof. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tubingen University Medical Center | Tübingen | Germany | ||||
| Meir Medical Center |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Kfar Saba |
| Israel |
| AMC Medical Center | Amsterdam | Netherlands |
| ZGT Medical Center | Hengelo | Netherlands |
| Radboud University Medical Center | Nijmegen | Netherlands |
| Vall D'Hebron Medical Center | Barcelona | Spain |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |