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Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.
The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder EpiCheck Urine Test | Experimental | Bladder EpiCheck Urine Test |
|
| Gold Standard | Active Comparator | Cystoscopy and pathology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder EpiCheck Urine Test | Device | The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard) | Day 1 | |
| Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives 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, MSc | Nucleix Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States | ||
| Chesapeake Urology Research Associates |
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|
| Cystoscopy and pathology | Procedure | Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy |
|
| Baltimore |
| Maryland |
| 21237 |
| United States |
| Michigan Institute of Urology, P.C. | Troy | Michigan | 48084 | United States |
| Metro Urology | Woodbury | Minnesota | 55125 | United States |
| Urological Surgeons of Long Island | Garden City | New York | 11530 | United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Urology San Antonio | San Antonio | Texas | 78229 | United States |
| University Of Washington | Seattle | Washington | 98195-6158 | United States |
| UHN, Princess Margret Cancer center | Toronto | Ontario | M5G 1Z5 | Canada |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| 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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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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