Bladder CancersNCT01264744
Detection of Chromosomal Aberrations in Urine Samples Using Fluorescent in Situ Hybridization (FISH) (UroVysion Test)
An observational study of Bladder Cancers, run by Applied Spectral Imaging Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancers
- How many people
- 174 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with hematuria that are suspected in having bladder carcinoma, and in patients previously diagnosed with bladder cancer.
Who may be able to join
- Well stained slides with bright FISH signals
Who cannot join
- Very old slides that were already bleached
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Hospital
Los Angeles, California, 90073
Sheila Dobin, Ph.D.
Temple, Texas, 76508
PLUS Diagnostics
Union, New Jersey, 07083
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Cancers
- Keywords
- Bladder cancer, Chromosomal aberrations, FISH, Urine sample
- Medical subject headings
- Urinary Bladder Neoplasms, Chromosome Aberrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Spectral Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sheila - Dobin, Ph.D., Study director, Section Chief, Cytogenetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264744
- Sponsor's protocol ID
- ASI-UroF
- Status last verified
- Dec 2010
- First submitted
- 21 Dec 2010
- Last updated
- 23 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Study for Detection of Chromosomal Aberrations Using FISH in Urine Samples Sections
- ClinicalTrials.gov ID
- NCT01264744
- Acronym / sponsor ID
- ASI-UroF
- Conditions
- Bladder Cancers
- Keywords
- Bladder cancer, Chromosomal aberrations, FISH, Urine sample
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Applied Spectral Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with hematuria that are suspected in having bladder carcinoma, and in patients previously diagnosed with bladder cancer.
Key inclusion criteria (1 listed)
- Well stained slides with bright FISH signals
Key exclusion criteria (1 listed)
- Very old slides that were already bleached
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila - Dobin, Ph.D. study director
Section Chief, Cytogenetics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancers, run by Applied Spectral Imaging Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2010.