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

Sponsor

Applied Spectral Imaging Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01264744

Collaborator

(none)

174

Enrollment

Locations

Duration (Months)

Patients Per Site

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancers

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 Design

Study Type:

Observational

Actual Enrollment :

174 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Well stained slides with bright FISH signals

Exclusion Criteria:

Very old slides that were already bleached

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Hospital	Los Angeles	California	United States	90073
2	PLUS Diagnostics	Union	New Jersey	United States	07083
3	Sheila Dobin, Ph.D.	Temple	Texas	United States	76508