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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01264744
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : December 23, 2010
Information provided by:
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.

Condition or disease
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 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 : November 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
Urine samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with hematuria that are suspected in having bladder carcinoma, and in patients previously diagnosed with bladder cancer.

Inclusion Criteria:

  • Well stained slides with bright FISH signals

Exclusion Criteria:

  • Very old slides that were already bleached

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01264744

United States, California
VA Hospital
Los Angeles, California, United States, 90073
United States, New Jersey
PLUS Diagnostics
Union, New Jersey, United States, 07083
United States, Texas
Sheila Dobin, Ph.D.
Temple, Texas, United States, 76508
Sponsors and Collaborators
Applied Spectral Imaging Ltd.
Study Director: Sheila - Dobin, Ph.D. Section Chief, Cytogenetics

Responsible Party: Nir Katzir, Applied Spectral Imaging Ltd. Identifier: NCT01264744     History of Changes
Other Study ID Numbers: ASI-UroF
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: December 23, 2010
Last Verified: December 2010

Keywords provided by Applied Spectral Imaging Ltd.:
Bladder cancer
Chromosomal aberrations
Urine sample

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Chromosome Aberrations
Chromosome Disorders
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Pathologic Processes
Congenital Abnormalities
Genetic Diseases, Inborn