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

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00975455 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ^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 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 ^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.

Sex/Gender

Sexes Eligible for Study:

All

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Ellen Sheets, MD, Predictive Biosciences

Study Sponsor ^ICMJE

Predictive Biosciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Predictive Biosciences

Verification Date

November 2009

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

To Top