- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01264744
Detection of Chromosomal Aberrations in Urine Samples Using Fluorescent in Situ Hybridization (FISH) (UroVysion Test)
December 22, 2010 updated by: Applied Spectral Imaging Ltd.
Concordance Study for Detection of Chromosomal Aberrations Using FISH in Urine Samples Sections
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
174
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90073
- VA Hospital
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New Jersey
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Union, New Jersey, United States, 07083
- PLUS Diagnostics
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Texas
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Temple, Texas, United States, 76508
- Sheila Dobin, Ph.D.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with hematuria that are suspected in having bladder carcinoma, and in patients previously diagnosed with bladder cancer.
Description
Inclusion Criteria:
- Well stained slides with bright FISH signals
Exclusion Criteria:
- Very old slides that were already bleached
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sheila - Dobin, Ph.D., Section Chief, Cytogenetics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
December 21, 2010
First Submitted That Met QC Criteria
December 21, 2010
First Posted (Estimate)
December 22, 2010
Study Record Updates
Last Update Posted (Estimate)
December 23, 2010
Last Update Submitted That Met QC Criteria
December 22, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASI-UroF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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