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

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.

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Key information

Conditions

Bladder Cancers Chromosome Aberrations Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Hospital, Los Angeles, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Well stained slides with bright FISH signals

Exclusion criteria

Very old slides that were already bleached

Sponsors and collaborators

Lead sponsor

Applied Spectral Imaging Ltd.

Industry

Registry information

Official study title

Concordance Study for Detection of Chromosomal Aberrations Using FISH in Urine Samples Sections

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 22, 2010
Registry last updated: Dec 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed