Urine Cytology and Utility in Bladder Recurrence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00971256
First received: September 2, 2009
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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


Condition
Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Urine Cytology and Utility in Bladder Recurrence

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Review bladder cancer patients and form a database in regards to urine cytology. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bladder cancer patients
Bladder cancer patients from one Beaumont Urologist.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with bladder cancer.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00971256

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

No publications provided

Responsible Party: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00971256     History of Changes
Other Study ID Numbers: 2009-144
Study First Received: September 2, 2009
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Bladder
Cancer
Cytology

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

ClinicalTrials.gov processed this record on October 20, 2014