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CompletedNCT00971256Updated Nov 23, 2011

Urine Cytology and Utility in Bladder Recurrence

An observational study in Bladder Cancer, sponsored by William Beaumont Hospitals. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-23.

Sponsored by William Beaumont Hospitals · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bladder Cancer

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Keywords

  • Bladder
  • Cancer
  • Cytology
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 10 is below the median of 200 across 702 observational studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
10 participants (actual)

Groups and cohorts

  • Bladder cancer patients

    Bladder cancer patients from one Beaumont Urologist.

06

What researchers measure

Primary outcomes

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

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00971256
Lead sponsor
William Beaumont Hospitals
Responsible party
Sponsor
First posted
Sep 3, 2009
Start date
Sep 2009
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Nov 23, 2011

Study contacts

Joseph Mashni, MD
principal investigator · Beaumont Hospitals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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