#0515

The Australian Urologic risk Stratification of patientS wIth hEmaturia (AUSSIE) Study of Cxbladder Performance for the Detection of Urothelial Carcinoma in Patients with Hematuria: Trial in Progress

V. Buhariwalla¹, K. Sethi¹, I. Vela², D. Hayne³, W. Ranasinghe⁴

¹Austin Health, Urology, Melbourne, Australia
²2Princess Alexandra Hospital, Urology, Brisbane, Australia
³3South Metropolitan Health Service, Urology, Perth, Australia
⁴Monash Health & Austin Health, Urology, Melbourne, Australia

Introduction:

Hematuria is a common symptom that may indicate the presence of urothelial carcinoma (UC). Cystoscopy is the gold standard tool for pathological diagnosis of UC; however, this invasive technique can be associated with significant healthcare costs, patient discomfort, and procedural complications, particularly among patients at low risk of UC. Cxbladder Triage Plus is a non-invasive, urinary diagnostic test that measures expression of 5 UC biomarkers, in combination with 6 single-nucleotide polymorphisms from FGFR3 and TERT, in patients with hematuria to identify those at low UC risk. Triage Plus has enhanced diagnostic performance over first-generation Cxbladder tests, providing high-sensitivity, high-specificity, risk stratification of patients presenting for hematuria evaluation. The clinical utility of Triage Plus is reduction in unnecessary cystoscopies in patients with low UC risk, while providing diagnostic accuracy in those with intermediate or high risk. The aim of the ongoing AUSSIE study is to clinically validate the performance of Triage Plus in patients presenting with hematuria in Australia

Material and methods:

AUSSIE is a multicenter, prospective, observational study that is recruiting an estimated 800 patients with hematuria across clinical sites in Australia. Eligibility criteria include microhematuria or gross hematuria, referral for investigative cystoscopy, and no previous UC diagnoses. Study enrollment has a target of ≥35 confirmed UC cases overall, including ≥10 confirmed UC cases from patients with microhematuria. Prior to undergoing cystoscopy, all patients provide a voided urine sample for processing using Triage Plus, with test outcomes compared against cystoscopy. The study design incorporates blinding, ensuring that Triage Plus results are unavailable to patients or clinicians during the study. Demographic data, risk classification according to 2025 AUA microhematuria guidelines, and clinical outcomes will also be recorded. The primary endpoint is the diagnostic performance (sensitivity, specificity, negative predictive value, positive predictive value, and test-negative rate) of Triage Plus when compared with cystoscopy findings, with corresponding 95% confidence intervals

Results:

Study recruitment is ongoing (546 of an expected 800) and will continue until the confirmed UC case target is met. The target is 10 UC confirmed from microhematuriua patients (currently 5) and at least 35 overall (currently 35). Last patient projected as August 2025