Microscopic or Gross Hematuria Clinical Trial
Official title:
Phase 3 Study of Hematuria Evaluation
| Verified date | November 2009 |
| Source | Predictive Biosciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1400 |
| Est. completion date | January 2011 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 45 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Community Care Physicians | Albany | New York |
| United States | Coastal Urology Associates | Brick | New Jersey |
| United States | The Urology Group | Cincinnati | Ohio |
| United States | Urology Clinics of North Texas | Dallas | Texas |
| United States | Atlantic Urological Associates | Daytona | Florida |
| United States | Eastern Urological Associates | Greenville | North Carolina |
| United States | Metropolitan Urology | Jeffersonville | Indiana |
| United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
| United States | Associates in Urology | Orange | New Jersey |
| United States | Winter Park Urology | Orlando | Florida |
| United States | Hudson Valley Urology | Poughkeepsie | New York |
| United States | Mayo Validation Support Services | Rochester | Minnesota |
| United States | Urology San Antonio Research | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Predictive Biosciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | No |