Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
ConditionUrothelial Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorPacific Edge Limited
About this trial
It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with the naked eye). This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
Able to give informed, written consent.
Able and willing to comply with study requirements (complete at-home urine sampling, fill in test request forms (TRFs) / tube labels and ship urine back to the central laboratory using a prepaid courier service).
Aged 18 years or older.
Disqualifiers
Prior history of bladder malignancy.
Reported Cxbladder results within the last six months.
Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC.
Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch).
Trial population
This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria (three or more red blood cells per high powered field in one urinalysis; no visible blood in the urine) and gross hematuria (visible blood in the urine) from US sites. This study will be conducted on subjects with microscopic or gross hematuria referred to urology and scheduled for cystoscopy for the investigation of urothelial carcinoma.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Cxbladder urine test
Diagnostic testCxbladder tests uses mRNA and DNA biomarkers in the urine to direct the management of UC from diagnosis to surveillance for disease recurrence.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
To validate the performance characteristics of Cxbladder Triage Plus in a US cohort which will consist of subjects with a recent history of hematuria and are referred to urology and scheduled for cystoscopy for the evaluation of hematuria.
Cxbladder Triage-Plus performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.
Time frame
Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedureSecondary outcomes
1
To validate the performance characteristics and Test Negative Rate of Cxbladder Triage Plus through sub-group analysis (gross hematuria, microscopic hematuria, inflammation) for patients with a recent history of hematuria who are undergoing cystoscopy
Cxbladder Triage test performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.
Time frame
Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure2
To evaluate the performance characteristics of both Cxbladder Triage Plus and Cxbladder Triage in a pooled analysis with combined results generated at other clinical sites, and to the results of other published clinical studies.
Cxbladder Triage test performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.
Time frame
Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedureSponsors and contacts
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Source ClinicalTrials.gov