Longitudinal Bladder Cancer Study for Tumour Recurrence
ConditionUrothelial Bladder Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPacific Edge Limited
About this trial
Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.
Subjects must agree to 4 successive study visits, including urine sample collection at each visit.
Physically able to provide a voided urine sample (a sample from catheterization is not eligible).
Able to give written informed consent
Disqualifiers
Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
Previous muscle invasive bladder tumour (pT2 or greater)
Known pregnancy
Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed.
Trial population
The study will recruit low-, intermediate-, and high-risk surveillance subjects (defined as per AUA/SUP Guidelines 2016, amendment 2020), previously diagnosed with urothelial carcinoma.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CxBladder Monitor/Monitor+
Diagnostic testCxBladder Monitor/Monitor+ is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.
Treatment groups
450 Participants
are divided into 1 treatment groupGroup A: Single arm - Patients undergoing surveillance for UC recurrence1 intervention
Trial outcomes
Primary outcomes
1
To clinically validate the performance characteristics of CxBladder Monitor/Monitor+
To clinically validate the performance characteristics - sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and test-negative rate of Monitor and Monitor+ for the detection of recurrent UC in subjects with a recent history of urinary tract UC who are being treated according to standard of care and are concurrently undergoing routine investigative cystoscopy.
Time frame
12 MonthsSponsors and contacts
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Source ClinicalTrials.gov