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Phase 3 Study of Hematuria Evaluation


N/A
45 Years
N/A
Not Enrolling
Both
Microscopic or Gross Hematuria

Thank you

Trial Information

Phase 3 Study of Hematuria Evaluation


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

Initial Visit only

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

PBS-002

NCT ID:

NCT00975455

Start Date:

July 2009

Completion Date:

January 2011

Related Keywords:

  • Microscopic or Gross Hematuria
  • Hematuria

Name

Location

Urology San Antonio ResearchSan Antonio, Texas  78229
Atlantic Urological AssociatesDaytona Beach, Florida  32114
Urology Clinics of North TexasDallas, Texas  75231
The Urology GroupCincinnati, Ohio  45212
Hudson Valley UrologyPoughkeepsie, New York  12601
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Metropolitan UrologyJeffersonville, Indiana  47130
Coastal Urology AssociatesBrick, New Jersey  08724
Community Care PhysiciansAlbany, New York  12208
Winter Park UrologyOrlando, Florida  32803
Mayo Validation Support ServicesRochester, Minnesota  55901
Associates in UrologyOrange, New Jersey  07052
Eastern Urological AssociatesGreenville, North Carolina  27834