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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.

Category

IRB Number
20210674HU
NCT Number
NCT03988309
Open to Enrollment
Yes

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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  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
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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


Regulatory Point of Contact
Robert Svatek
(210) 567-5676
svatek@uthscsa.edu

Regulatory Point of Contact
Grace Ihsiu Todd
210-567-5643
toddg@uthscsa.edu

Local Recruitment Point of Contact
Grace Ihsiu Todd
210-567-5643
toddg@uthscsa.edu

Principal Investigator
Robert Svatek