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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 10, 2009
Last Updated Date	June 7, 2011
Start Date ^ICMJE	July 2009
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00975455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer
Official Title ^ICMJE	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 ^ICMJE	Observational
Study Design ^ICMJE	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 ^ICMJE	Microscopic or Gross Hematuria
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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 ^ICMJE	Completed
Estimated Enrollment ^ICMJE	1400
Completion Date	January 2011
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	45 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United States
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00975455
Other Study ID Numbers ^ICMJE	PBS-002
Has Data Monitoring Committee	No
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Ellen Sheets, MD, Predictive Biosciences
Study Sponsor ^ICMJE	Predictive Biosciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Predictive Biosciences
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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