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To evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.
This study will sample urine provided by bladder cancer patients as part of their normal routine surveillance screening. No additional effort will be required from the patients and only modest additional effort from the study staff. Some de-identified patient medical information may also be requested, including concominant medications, relevant current or previous diseases, prior bladder cancer interventions and other relevant information to ensure there are no interfering substances or other confounders that could affect study results. There is no risk to patients as the normal diagnostics for bladder cancer will be followed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Tumor Positive | Patients with previous bladder cancer diagnosis; any stage and histological type, undergoing cystoscopy or suspected bladder tumor undergoing surveillance cystoscopy. | ||
| Bladder Tumor Negative | Patients with no suspected bladder tumor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Successful identification of bladder tumor biomarkersBiomarkers in Patients Under Active BCa Surveillance | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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This study will sample urine provided by bladder cancer patients as part of their normal routine surveillance screening. No additional effort or samples will be required from the patients. Results from this study will not be used for any of the normal physician diagnostic process. Patients will have a suspected bladder tumor undergoing cystoscopy or a history of bladder cancer undergoing surveillance cystoscopy. Patients who have had a positive diagnosis of bladder cancer, but have not yet had a tumor resection (known BCa positive patients) are highly desirable for this study. It is anticipated that the majority of samples collected will be negative. In the case of a known BCa positive patient, the sponsor is requested
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodney Brenneman | Contact | 949-433-6007 | rbrenneman@phagetech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint John's Health Center and the Saint John's Cancer Institute | Recruiting | Santa Monica | California | 90404 | United States |
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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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| 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 |