NCT01264744

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 174 (actual)
• Sponsor: Applied Spectral Imaging Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancers

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-12-22
• Last updated: 2010-12-23

Locations

3 sites across 1 country: United States