Brief Title: Efficacy and Utility of Cxbladder Tests in Hematuria Patients

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.

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

Primary Outcome 2 - Measure: Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.

Primary Outcome 2 - Timeframe: Time Frame: 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 (by either flexible or rigid cystoscopy/TURBT), including hematuria patients 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

- 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: (612) 467-5601

Email: mcrisk@umn.edu

LOCATION