Lay Description

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.


IRB Number
NCT Number
Open to Enrollment


Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria


  1. 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.
  2. Able to provide a voided urine sample of the required minimum volume
  3. Able to give written consent
  4. Able and willing to comply with study requirements
  5. Aged 18 years or older

Exclusion Criteria

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

Study Design

Arm Groups

Study Contact

Karl Norton
(210) 450-9630

Brandi Weaver
(210) 567-0158

Principal Investigator
Robert Svatek