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

Completed

• Conditions: Bladder Cancers

• Registration Number: NCT01264744
• Lead Sponsor: Applied Spectral Imaging Ltd.

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.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-12
• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Last Update Submitted: 2010-12-22
• Last Update Posted: 2010-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Well stained slides with bright FISH signals

Exclusion Criteria

• Very old slides that were already bleached

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

VA Hospital; 🇺🇸 Los Angeles, California, United States

PLUS Diagnostics; 🇺🇸 Union, New Jersey, United States

Sheila Dobin, Ph.D.; 🇺🇸 Temple, Texas, United States