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Diagnostic Test

patients with hematuria undergoing investigation for UC for Blood in Urine

N/A
Waitlist Available
Research Sponsored by Pacific Edge Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the outcome measure will be assessed by 6 months after trial completion.
Awards & highlights
No Placebo-Only Group

Summary

Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.

Eligible Conditions
  • Blood in Urine
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the outcome measure will be assessed by 6 months after trial completion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome measure will be assessed by 6 months after trial completion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.
Urinary Bladder
Secondary study objectives
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites
Cystoscopy
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: patients with hematuria undergoing investigation for UCExperimental Treatment1 Intervention
Patients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria. Microscopic hematuria is defined as \> 3 red blood cells per high-powered microscopy field for a properly collected urine sample.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cxbladder
2013
N/A
~810

Find a Location

Who is running the clinical trial?

Pacific Edge LimitedLead Sponsor
7 Previous Clinical Trials
4,107 Total Patients Enrolled
Tony Lough, PhDStudy ChairPacific Edge Pty Ltd
3 Previous Clinical Trials
2,554 Total Patients Enrolled
~116 spots leftby Oct 2025
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