Clinical trial NCT00975455: Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer
Official title: Phase 3 Study of Hematuria Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microscopic or Gross Hematuria
Lead sponsor: Predictive Biosciences
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 1400
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be selected from Urology and Oncology practices.

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.


Eligibility 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.

Primary outcomes:
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
timeFrame: Initial Visit only
Secondary outcomes:
measure: 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.
timeFrame: Initial Visit
Other outcomes:
Locations:
city: Daytona
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology
state: Florida
city: Jeffersonville
country: United States
facility: Metropolitan Urology
state: Indiana
city: Rochester
country: United States
facility: Mayo Validation Support Services
state: Minnesota
city: Brick
country: United States
facility: Coastal Urology Associates
state: New Jersey
city: Orange
country: United States
facility: Associates in Urology
state: New Jersey
city: Albany
country: United States
facility: Community Care Physicians
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology
state: New York
city: Greenville
country: United States
facility: Eastern Urological Associates
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
Study officials:
References: