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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00975455
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : June 8, 2011
Information provided by:
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.

Condition or disease
Microscopic or Gross Hematuria

Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase 3 Study of Hematuria Evaluation
Study Start Date : July 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Subjects with hematuria

Primary Outcome Measures :
  1. 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 [ Time Frame: Initial Visit only ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Initial Visit ]

Biospecimen Description:
urine sample

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects will be selected from Urology and Oncology practices.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00975455

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

Responsible Party: Ellen Sheets, MD, Predictive Biosciences Identifier: NCT00975455     History of Changes
Other Study ID Numbers: PBS-002
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: November 2009

Additional relevant MeSH terms:
Urination Disorders
Urologic Diseases
Pathologic Processes