Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-09 @ 1:58 PM
Study NCT ID:
NCT00971256
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2009-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urine Cytology and Utility in Bladder Recurrence
Sponsor:
Corewell Health East
Organization:
Study Overview
Official Title:
Urine Cytology and Utility in Bladder Recurrence
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: