Urine Cytology and Utility in Bladder Recurrence

Bladder Cancer Clinical Trial

Official title:

Urine Cytology and Utility in Bladder Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971256
• Other study ID #: 2009-144
• Status: Completed
• Phase: N/A
• First received: September 2, 2009
• Last updated: November 22, 2011
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: November 2011
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bladder Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Review bladder cancer patients and form a database in regards to urine cytology.		1 month	No