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

This study has been completed.
Sponsor:
Information provided by:
Predictive Biosciences
ClinicalTrials.gov Identifier:
NCT00975455
First received: September 10, 2009
Last updated: June 7, 2011
Last verified: November 2009
  Purpose

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
Microscopic or Gross Hematuria

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase 3 Study of Hematuria Evaluation

Resource links provided by NLM:


Further study details as provided by Predictive Biosciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Description:

urine sample


Estimated Enrollment: 1400
Study Start Date: July 2009
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with hematuria

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects will be selected from Urology and Oncology practices.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975455

Locations
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
  More Information

No publications provided

Responsible Party: Ellen Sheets, MD, Predictive Biosciences
ClinicalTrials.gov Identifier: NCT00975455     History of Changes
Other Study ID Numbers: PBS-002
Study First Received: September 10, 2009
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hematuria
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014