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The purpose of the study is the identification of chromosomal aberrations in urine samples.
The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of UroVysion FISH stained Urine samples.
The FISH test detect chromosomal aberrations in urine specimens from persons with hematuria suspected of having bladder cancerous using the UroVysion® Bladder Cancer Kit (UroVysion Kit) which is FDA approved. This kit is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
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Inclusion Criteria:
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patients with hematuria that are suspected in having bladder carcinoma, and in patients previously diagnosed with bladder cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Sheila - Dobin, Ph.D. | Section Chief, Cytogenetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Hospital | Los Angeles | California | 90073 | United States | ||
| PLUS Diagnostics |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002869 | Chromosome Aberrations |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Urine samples
| Union |
| New Jersey |
| 07083 |
| United States |
| Sheila Dobin, Ph.D. | Temple | Texas | 76508 | United States |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |