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
Qualifiers
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 design
Treatments tested in this trial
- Cxbladder urine test