Urine Cytology and Utility in Bladder Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00971256
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : November 23, 2011
Information provided by (Responsible Party):
William Beaumont Hospitals

Brief Summary:
Review bladder cancer patients and form a database in regards to urine cytology.

Condition or disease
Bladder Cancer

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 Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Urine Cytology and Utility in Bladder Recurrence
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Bladder cancer patients
Bladder cancer patients from one Beaumont Urologist.

Primary Outcome Measures :
  1. Review bladder cancer patients and form a database in regards to urine cytology. [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with bladder cancer.

Inclusion Criteria:

  • Bladder cancer patients from Dr. Jay Hollander's private practice.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00971256

Sponsors and Collaborators
William Beaumont Hospitals
Principal Investigator: Joseph Mashni, MD Beaumont Hospitals

Responsible Party: William Beaumont Hospitals Identifier: NCT00971256     History of Changes
Other Study ID Numbers: 2009-144
First Posted: September 3, 2009    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011

Keywords provided by William Beaumont Hospitals:

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes