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

September 10, 2009
June 7, 2011
July 2009
November 2010   (final data collection date for primary 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 [ Time Frame: Initial Visit only ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00975455 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer
Phase 3 Study of Hematuria Evaluation

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided

urine sample

Probability Sample

Subjects will be selected from Urology and Oncology practices.

Microscopic or Gross Hematuria
Not Provided
Subjects with hematuria
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1400
January 2011
November 2010   (final data collection date for primary outcome measure)

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.
Both
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00975455
PBS-002
No
Ellen Sheets, MD, Predictive Biosciences
Predictive Biosciences
Not Provided
Not Provided
Predictive Biosciences
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP