Validation of Cxbladder Triage-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE)
It is of current debate whether the use of invasive (referring to a process that requires insertion into the body) standard of care procedures such as a cystoscopy which is a procedure to look inside the bladder using a thin camera called a cystoscope, is appropriate for use in patients with microscopic hematuria or blood in urine invisible to 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 a cystoscopy comes with anxiety and pain, in addition to other potential side effects. This has resulted in low admittance in urology clinics for cystoscopy with hematuria (blood in urine) patients. Therefore, there is a need for a more simple, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. There is a potential role Cxbladder, a non-invasive, urine based test, can fill this role.
• Subject is referred to urology and scheduled for cystoscopy for the evaluation of microscopic hematuria after recent confirmed microscopic hematuria presentation by urine microscopy of three or more RBC/HPF.
• 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.