Longitudinal Bladder Cancer Study for Tumour Recurrence

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

Qualifiers

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 design

Treatments tested in this trial

  • CxBladder Monitor/Monitor+

Treatment groups

450 Participants
are divided into 1 treatment group

Sponsors and collaborators