Brief Title: Cxbladder Hematuria Clinical Utility Study

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder is used in the evaluation

Primary Outcome 1 - Timeframe: The outcome measure will be assessed by 6 months after trial completion.

CONDITION

• Hematuria
• Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
Patient is undergoing investigation of recent confirmed hematuria, as defined by the AUA/SUFU Guideline (Barocas DA, Boorjian SA, Alvarez RD et al. Microhematuria: AUA/SUFU guideline, J Urol 2020; 204:778) (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 or pelvic radiotherapy. Prior history prostate or renal cell carcinoma within the last 5 years.

- Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,

- Known current pregnancy

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Tony Lough, PhD

Role: Study Chair

Affiliation: Pacific Edge Pty Ltd

Overall Contact

Name: Tony Lough, PhD

Phone: 2146458764

Email: yair.lotan@utsouthwestern.edu

LOCATION