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

Completed

• Conditions: Microscopic or Gross Hematuria

• Registration Number: NCT00975455
• Lead Sponsor: Predictive Biosciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Status Verified: 2009-11
• Primary Completion: 2010-11
• Study Completion: 2011-01
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the performance characteristics of the Predictive Biosciences Assay relative to the cystoscopy results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria	Initial Visit only

Secondary Outcome Measures

Name	Time	Method
To establish the performance characteristics of the PB assay relative to urine cytology results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria.	Initial Visit

Trial Locations

Locations (13)

Atlantic Urological Associates; 🇺🇸 Daytona, 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

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