Bladder CancerNCT00971256
Urine Cytology and Utility in Bladder Recurrence
An observational study of Bladder Cancer, run by Corewell Health East.
Trial summary
Review bladder cancer patients and form a database in regards to urine cytology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with bladder cancer.
Who may be able to join
- Bladder cancer patients from Dr. Jay Hollander's private practice.
Who cannot join
- Patients with diagnosis of bladder cancer without initial cytology available.
- Patients who received outside nephrectomy or cystectomy without pathology available.
- Those who had recurrence without cytology results available.
- Those who were followed by Dr Hollander and another urologist in which records are missing for a significant number of follow ups.
About this study
Review bladder cancer patients and form a database in regards to urine cytology.
Read the detailed description
In 2008 there was an estimated 68,810 new cases of bladder cancer, and 14,100 deaths. On the list of morbidity due to cancer, bladder cancer ranks number nine, yet is number one in dollars spent per cancer diagnosis and treatment.
Guidelines include cystoscopy and cytology/urine study every three months for the first 2 years and then every 6 months for the next 2 years, with the cycle being reset with every recurrence.
Urine cytology currently considered the gold standard for urine tests has many pros and cons. The points that keep it in use include: its high specificity, the ability to detect upper tract occurrence, and the ability to monitor the small population of those with bladder cancer whose disease becomes more aggressive. Opponents to cytology refer to the fact that is has low sensitivity that it is fairly subjective and that newer markers in comparison are improved.
There are multiple journal article which document the performance of cytology and the newer markers, the new markers versus cytology and then the performance of cytology in tandem with these new markers. The bottom line that is often overlooked is that cytology is expensive and each of the newer markers are at least as expensive as cytology. With the fact that a person who is diagnosed with non invasive bladder cancer can have up to 13 urine cytology's in 5 years without any recurrence we believe newer rational recommendations need to be made in regards to urine studies and bladder cancer follow up.
- Conditions
- Bladder Cancer
- Keywords
- Bladder, Cancer, Cytology
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bladder cancer patients | Bladder cancer patients from one Beaumont Urologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Review bladder cancer patients and form a database in regards to urine cytology.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Mashni, MD, Principal investigator, Beaumont Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971256
- Sponsor's protocol ID
- 2009-144
- Status last verified
- Nov 2011
- First submitted
- 2 Sep 2009
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Cytology and Utility in Bladder Recurrence
- ClinicalTrials.gov ID
- NCT00971256
- Acronym / sponsor ID
- 2009-144
- Conditions
- Bladder Cancer
- Keywords
- Bladder, Cancer, Cytology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Sep 2009 (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.
Review bladder cancer patients and form a database in regards to urine cytology.
Detailed description
In 2008 there was an estimated 68,810 new cases of bladder cancer, and 14,100 deaths. On the list of morbidity due to cancer, bladder cancer ranks number nine, yet is number one in dollars spent per cancer diagnosis and treatment.
Guidelines include cystoscopy and cytology/urine study every three months for the first 2 years and then every 6 months for the next 2 years, with the cycle being reset with every recurrence.
Urine cytology currently considered the gold standard for urine tests has many pros and cons. The points that keep it in use include: its high specificity, the ability to detect upper tract occurrence, and the ability to monitor the small population of those with bladder cancer whose disease becomes more aggressive. Opponents to cytology refer to the fact that is has low sensitivity that it is fairly subjective and that newer markers in comparison are improved.
There are multiple journal article which document the performance of cytology and the newer markers, the new markers versus cytology and then the performance of cytology in tandem with these new markers. The bottom line that is often overlooked is that cytology is expensive and each of the newer markers are at least as expensive as cytology. With the fact that a person who is diagnosed with non invasive bladder cancer can have up to 13 urine cytology's in 5 years without any recurrence we believe newer rational recommendations need to be made in regards to urine studies and bladder cancer follow up.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder cancer patients | – | –Bladder cancer patients from one Beaumont Urologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with bladder cancer.
Key inclusion criteria (1 listed)
- Bladder cancer patients from Dr. Jay Hollander's private practice.
Key exclusion criteria (4 listed)
- Patients with diagnosis of bladder cancer without initial cytology available.
- Patients who received outside nephrectomy or cystectomy without pathology available.
- Those who had recurrence without cytology results available.
- Those who were followed by Dr Hollander and another urologist in which records are missing for a significant number of follow ups.
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
Review bladder cancer patients and form a database in regards to urine cytology.
Time frame: 1 month
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 Nov 2011.
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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.
Joseph Mashni, MD principal investigator
Beaumont Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Corewell Health East.
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 4 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 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Review bladder cancer patients and form a database in regards to urine cytology. (time frame: 1 month). It is what the study was designed to measure, not a finding.
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 Nov 2011.