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This is a prospective, multicenter observational study designed to collect urine and tumor biospecimens and associated clinical data from patients undergoing evaluation, treatment, or surveillance for urothelial carcinoma.
All study participants will provide a urine sample at baseline, study enrollment. Each participant will then be followed longitudinally for up to 5 years during which urine, tissue (if applicable), and clinical data will be collected from the standard of care clinical visits. Urine samples will be collected in Convergent Genomics' proprietary urine collection system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Cancer and/or Upper Tract Urothelial Cell Carcinoma (UCC) | |||
| Hematuria Controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Free Survival (RFS) | RFS is defined as the time from the urine specimen collection to the first histopathologically confirmed recurrence of urothelial carcinoma | From enrollment through completion of available clinical follow-up, up to 5 years. |
| Diagnostic Detection Performance in Hematuria Triage | Sensitivity, specificity, positive predictive value and negative predictive value of the investigational urine assay for the detection of urothelial cancer among subjects undergoing evaluation for hematuria, comparing subjects with histopathologically confirmed cancer to subjects without evidence of cancer at the time of diagnostic workup. | From enrollment through completion of diagnostic evaluation, up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison to Alternative Urine Biomarkers | Comparison of the investigational urine biomarker to alternative urine biomarker assays, including cytology and UroVysion FISH, for the detection of urothelial cancer recurrence. Comparison will include lead time, sensitivity, specificity, negative predictive value, and positive predictive value. | From enrollment up to 5 years. |
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Inclusion Criteria:
GROUP 1: Bladder Cancer and/or Upper Tract UCC
GROUP 2: Hematuria Controls
Exclusion Criteria:
GROUP 1: Bladder Cancer and/or Upper Tract UCC
GROUP 2: Hematuria Controls
- Evidence and/or History of bladder cancer, upper tract UCC, kidney cancer and/or prostate cancer at the time of collection
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Adult patients undergoing evaluation, treatment, or surveillance for urologic tract cancers, including bladder cancer, upper tract urothelial cell carcinoma, or urethral urothelial cell carcinoma, as well as individuals undergoing evaluation for hematuria. Participants are identified and enrolled at participating clinical sites.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology San Diego | Active, not recruiting | Oceanside | California | 92056 | United States | |
Deidentified patient data, inclusive of clinical risk factors, tumor staging and recurrence outcomes.
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| Lead Time for Detection of Cancer Recurrence | A subject with diagnostic lead time will be defined as a subject with a negative cystoscopy and concurrent positive investigational urine biomarker with confirmed urothelial cancer recurrence on study. Lead time will be calculated as the time from the positive urine biomarker result to the date of histopathologic confirmation. | From enrollment up to 5 years. |
| Genesis Research, LLC |
| Active, not recruiting |
| San Diego |
| California |
| 92123 |
| United States |
| Urology Associates of Silicon Valley | Active, not recruiting | San Jose | California | 95124 | United States |
| UroPartners, LLC | Active, not recruiting | Chicago | Illinois | 60657 | United States |
| UroPartners, LLC | Active, not recruiting | Grayslake | Illinois | 60030 | United States |
| UroPartners, LLC | Active, not recruiting | Mount Prospect | Illinois | 60056 | United States |
| UroPartners, LLC | Active, not recruiting | Niles | Illinois | 60068 | United States |
| UroPartners, LLC | Active, not recruiting | Wheaton | Illinois | 60187 | United States |
| Chesapeake Urology Research Associates | Active, not recruiting | Hanover | Maryland | 21076 | United States |
| Comprehensive Urology | Active, not recruiting | Royal Oak | Michigan | 48073 | United States |
| Sheldon J. Freedman MD LTD | Active, not recruiting | Las Vegas | Nevada | 89144 | United States |
| Manhattan Medical Research Practice | Active, not recruiting | New York | New York | 10016 | United States |
| The Urology Group | Active, not recruiting | Cincinnati | Ohio | 45212 | United States |
| Urology Associates, P.C. | Active, not recruiting | Nashville | Tennessee | 37209 | United States |
| Urology Austin - Round Rock | Active, not recruiting | Austin | Texas | 78681 | United States |
| Midtown Urology Associates | Active, not recruiting | Austin | Texas | 78705 | United States |
| Urology Austin - Medical Park Tower | Active, not recruiting | Austin | Texas | 78759 | United States |
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| Urology San Antonio | Active, not recruiting | San Antonio | Texas | 78229 | United States |
| UT Health San Antonio | Active, not recruiting | San Antonio | Texas | 78229 | United States |
| Urology of Virginia | Active, not recruiting | Virginia Beach | Virginia | 23462 | United States |
| Ashford Med Center | Active, not recruiting | San Juan | 00907 | Puerto Rico |
| PanOncology | Active, not recruiting | San Juan | 00935 | Puerto Rico |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D006417 | Hematuria |
| D000093284 | Non-Muscle Invasive 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014555 | Urination Disorders |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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