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


N/A
N/A
N/A
Not Enrolling
Both
Bladder Cancers

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Trial Information

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


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.


Inclusion Criteria:



- Well stained slides with bright FISH signals

Exclusion Criteria:

- Very old slides that were already bleached

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Principal Investigator

Sheila - Dobin, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Section Chief, Cytogenetics

Authority:

United States: Institutional Review Board

Study ID:

ASI-UroF

NCT ID:

NCT01264744

Start Date:

November 2009

Completion Date:

August 2010

Related Keywords:

  • Bladder Cancers
  • Bladder cancer
  • Chromosomal aberrations
  • FISH
  • Urine sample
  • Urinary Bladder Neoplasms
  • Chromosome Aberrations
  • Chromosome Disorders

Name

Location

PLUS DiagnosticsLakewood, New Jersey  08701
VA HospitalLos Angeles, California  90073
Sheila Dobin, Ph.D.Temple, Texas  76508