Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer

Completed

Conditions studied: Microscopic or Gross Hematuria

In brief

The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.

Key facts

Study ID

NCT00975455

Run by

Predictive Biosciences

People needed

1400

Starts

2009-07-01

Expected to finish

2011-01-01

Last updated by the study team

2011-06-08

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older.
• Subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking.
• Subject must have an intact bladder
• Subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria.
• Subject must be able to provide a minimum of 25 mL of urine for study purposes.
• Urine samples must be available prior to cystoscopy, bladder biopsy, and TUR.
• Subjects must be willing to sign an Institutional Review Board approved written informed consent prior to any study related procedures being performed.

You may not qualify if…

• Subject had a history or current diagnosis of any basal or squamous cell cancer.
• Subject had a known diagnosis of any autoimmune disease.
• Subject had known diagnosis of HIV, HCV or HBV
• Subject had disclosed voluntarily history of or current infection with TB or other systemic disease.
• Subject is currently pregnant or lactating.
• Subject had surgery within 30 days prior to enrollment
• Subject has known allergy to benzalkonium chloride.
• Subject participated in an investigational drug or device trial within 30 days prior to enrollment.

Where it is running

• Atlantic Urological Associates — Daytona Beach, Florida, United States
• Winter Park Urology — Orlando, Florida, United States
• Metropolitan Urology — Jeffersonville, Indiana, United States
• Mayo Validation Support Services — Rochester, Minnesota, United States
• Coastal Urology Associates — Brick, New Jersey, United States
• Associates in Urology — Orange, New Jersey, United States
• Community Care Physicians — Albany, New York, United States
• Hudson Valley Urology — Poughkeepsie, New York, United States
• Eastern Urological Associates — Greenville, North Carolina, United States
• The Urology Group — Cincinnati, Ohio, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Clinics of North Texas — Dallas, Texas, United States
• Urology San Antonio Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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