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This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Healthy subjects and urology patients without prior history or evidence of bladder cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder EpiCheck | Diagnostic Test | Bladder EpiCheckTM (EpiCheck) is a urine test for monitoring of recurrence of NMIBC based on analysis of 15 informative DNA methylation biomarkers. |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population. | Day 1 |
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Inclusion Criteria:
Age 22 or older
Able to sign the informed consent form
Normal, healthy subjects or subjects with one of the following conditions:
Subjects with native bladder
Exclusion Criteria:
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Healthy subjects and urology patients without prior history or evidence of bladder cancer will be recruited from urology group clinics.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology San Antonio | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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