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

Bladder Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264744
• Other study ID #: ASI-UroF
• Status: Completed
• Phase: N/A
• First received: December 21, 2010
• Last updated: December 22, 2010
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: December 2010
• Source: Applied Spectral Imaging Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Well stained slides with bright FISH signals

Exclusion Criteria:

• Very old slides that were already bleached

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bladder Cancers
• Chromosome Aberrations
• Chromosome Disorders
• Urinary Bladder Neoplasms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Applied Spectral Imaging Ltd.

Country where clinical trial is conducted

United States,