---
title: Detection of Chromosomal Aberrations in Urine Samples Using Fluorescent in Situ Hybridization (FISH) (UroVysion Test)
nct_id: NCT01264744
overall_status: COMPLETED
sponsor: Applied Spectral Imaging Ltd.
study_type: OBSERVATIONAL
primary_condition: Bladder Cancers
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01264744.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01264744"
ct_last_update_post_date: 2010-12-23
last_seen_at: "2026-05-12T06:35:13.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Detection of Chromosomal Aberrations in Urine Samples Using Fluorescent in Situ Hybridization (FISH) (UroVysion Test)

**Official Title:** Concordance Study for Detection of Chromosomal Aberrations Using FISH in Urine Samples Sections

**NCT ID:** [NCT01264744](https://clinicaltrials.gov/study/NCT01264744)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 174
- **Lead Sponsor:** Applied Spectral Imaging Ltd.
- **Conditions:** Bladder Cancers
- **Start Date:** 2009-11
- **Completion Date:** 2010-08
- **CT.gov Last Update:** 2010-12-23

## Brief Summary

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.

## Detailed Description

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.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Well stained slides with bright FISH signals

Exclusion Criteria:

* Very old slides that were already bleached
```

## Locations (3)

- VA Hospital, Los Angeles, California, United States
- PLUS Diagnostics, Union, New Jersey, United States
- Sheila Dobin, Ph.D., Temple, Texas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.va hospital|los angeles|california|united states` — added _(2026-05-12)_
- `locations.plus diagnostics|union|new jersey|united states` — added _(2026-05-12)_
- `locations.sheila dobin, ph.d.|temple|texas|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01264744*  
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