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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00975455

Enrollment

1400

Registered

2009-09-11

Start date

2009-07-31

Completion date

2011-01-31

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microscopic or Gross Hematuria

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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	Initial Visit only

Secondary

Measure	Time frame
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.	Initial Visit

Countries

United States

Outcome results