The Cxbladder Hematuria Clinical Utility Study

  • days left to enroll
  • participants needed
  • sponsor
    Pacific Edge Limited
Updated on 25 January 2021
transurethral resection of bladder tumor


To evaluate the clinical utility associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of urothelial carcinoma (UC) without compromising detection of UC.


Randomised two arm pragmatic clinical study to be conducted at multiple sites in US and Canada. The trial will recruit hematuria subjects, presenting to qualified sites (academic, community), who are being evaluated for urothelial carcinoma (UC). Up to 100 consecutive eligible subjects will be recruited per site.

Condition Hemorrhage, Transitional cell carcinoma, Hematuria, Urothelial Carcinoma, haematuria
Treatment Cxbladder
Clinical Study IdentifierNCT03988309
SponsorPacific Edge Limited
Last Modified on25 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Hematuria or Hemorrhage or Urothelial Carcinoma or Transitional cell carcinoma?
Do you have any of these conditions: Urothelial Carcinoma or haematuria or Hemorrhage or Hematuria or Transitional cell carcinoma?
Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria subjects referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma
Able to provide a voided urine sample of the required minimum volume
Able to give written consent
Able and willing to comply with study requirements
Aged 18 years or older

Exclusion Criteria

Prior history of bladder malignancy, prostate or renal cell carcinoma
Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
History of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
Previous alkylating based chemotherapy
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