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

This study has been completed.
Sponsor:
Information provided by:
Applied Spectral Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01264744
First received: December 21, 2010
Last updated: December 22, 2010
Last verified: December 2010
History of Changes
  Purpose

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
Bladder Cancers

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Concordance Study for Detection of Chromosomal Aberrations Using FISH in Urine Samples Sections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Applied Spectral Imaging Ltd.:

Biospecimen Retention:   Samples Without DNA

Urine samples


Enrollment: 174
Study Start Date: November 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Well stained slides with bright FISH signals

Exclusion Criteria:

  • Very old slides that were already bleached
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264744

Locations
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.
Investigators
Study Director: Sheila - Dobin, Ph.D. Section Chief, Cytogenetics
  More Information

No publications provided

Responsible Party: Nir Katzir, Applied Spectral Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01264744     History of Changes
Other Study ID Numbers: ASI-UroF
Study First Received: December 21, 2010
Last Updated: December 22, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013