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Detection of Chromosomal Aberrations in Urine Samples Using Fluorescent in Situ Hybridization (FISH) (UroVysion Test)

NCT ID: NCT01264744

Last Updated: 2010-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bladder Cancers

Keywords

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Bladder cancer Chromosomal aberrations FISH Urine sample

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Well stained slides with bright FISH signals

Exclusion Criteria

* Very old slides that were already bleached
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Applied Spectral Imaging Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Applied Spectral Imaging Ltd.

Principal Investigators

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Sheila - Dobin, Ph.D.

Role: STUDY_DIRECTOR

Section Chief, Cytogenetics

Locations

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VA Hospital

Los Angeles, California, United States

Site Status

PLUS Diagnostics

Union, New Jersey, United States

Site Status

Sheila Dobin, Ph.D.

Temple, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ASI-UroF

Identifier Type: -

Identifier Source: org_study_id