Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer
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ClinicalTrials.gov Identifier: NCT00975455 |
Recruitment Status
:
Completed
First Posted
: September 11, 2009
Last Update Posted
: June 8, 2011
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Sponsor:
Predictive Biosciences
Information provided by:
Predictive Biosciences
Tracking Information | |||
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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 |
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 |
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 |
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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. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |