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

Tracking Information
First Submitted Date	September 10, 2009
First Posted Date	September 11, 2009
Last Update Posted Date	June 8, 2011
Study Start Date	July 2009
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: September 10, 2009)	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 ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00975455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: September 10, 2009)	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 ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	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
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	urine sample
Sampling Method	Probability Sample
Study Population	Subjects will be selected from Urology and Oncology practices.
Condition	Microscopic or Gross Hematuria
Intervention	Not Provided
Study Groups/Cohorts	Subjects with hematuria
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: September 10, 2009)	1400
Original Estimated Enrollment	Same as current
Actual Study Completion Date	January 2011
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
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.
Sex/Gender	Sexes Eligible for Study: All
Ages	45 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00975455
Other Study ID Numbers	PBS-002
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ellen Sheets, MD, Predictive Biosciences
Study Sponsor	Predictive Biosciences
Collaborators	Not Provided
Investigators	Not Provided
PRS Account	Predictive Biosciences
Verification Date	November 2009