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

Phase 3 Study of Hematuria Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Microscopic or Gross Hematuria

• Study Type: Observational
• Enrollment (Anticipated): 1400

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona, Florida, United States, 32114
      • Atlantic Urological Associates
    • Orlando, Florida, United States, 32803
      • Winter Park Urology
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • Metropolitan Urology
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Validation Support Services
  • New Jersey
    • Brick, New Jersey, United States, 08723
      • Coastal Urology Associates
    • Orange, New Jersey, United States, 07052
      • Associates in Urology
  • New York
    • Albany, New York, United States, 12208
      • Community Care Physicians
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Urology
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Eastern Urological Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects will be selected from Urology and Oncology practices.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects with hematuria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Predictive Biosciences

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 10, 2009
• First Submitted That Met QC Criteria: September 10, 2009
• First Posted (Estimate): September 11, 2009

Study Record Updates

• Last Update Posted (Estimate): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Hemorrhage; Urination Disorders; Hematuria
• Other Study ID Numbers: PBS-002