The AUSSIE study: preliminary evaluation of Cxbladder Triage plus for urothelial carcinoma detection in patients with haematuria.

Abstract

Introduction & Objectives: Urothelial carcinoma (UC) is commonly indicated by haematuria. Patients presenting with haematuria require further evaluation to confirm a UC diagnosis, with cystoscopy being the gold standard method. However, cystoscopy is invasive, may be associated with complications, healthcare costs, and patient discomfort, and may not be essential in those at low UC risk. Cxbladder Triage Plus is a non-invasive, urinary diagnostic assay that identifies patients with haematuria at low UC risk by measuring expression of 5 UC biomarkers, plus 6 single-nucleotide variants from FGFR3 and TERTgenes. Thus, Triage Plus could reduce the number of unnecessary cystoscopies in patients with low UC risk, while providing diagnostic accuracy in those with intermediate or high risk. The AUSSIE study aims to validate the diagnostic performance of Triage Plus in patients presenting with haematuria in Australia. Method(s): The multicenter, prospective, observational AUSSIE study is being conducted across 4 clinical sites. Eligible patients have non-visible haematuria (NVH) or visible haematuria (VH), cystoscopy referral, and no prior UC diagnosis. Enrollment targeted >=35 confirmed UC cases (>=10 from patients with NVH). Before cystoscopy, patients provide a voided urine sample for Triage Plus testing, with outcomes compared against cystoscopy. The primary endpoint is the diagnostic performance of Triage Plus (sensitivity, specificity, NPV, PPV and test-negative rate) when compared with cystoscopy findings, with corresponding 95% CI. Result(s): At the end of recruitment including unmonitored data, 747 patients were enrolled (63.7% male; 39.2% aged >=70 years; Table 1). Haematuria status was VH in 457 patients (61.2%) and NVH in 275 (36.8%). AUA risk stratification was completed for 616 patients, of whom 543 (88.1%) had high UC risk and 73 (11.9%) had intermediate risk. UC was confirmed by cystoscopy in 53 patients (8 with NVH). The study will complete recruitment in October 2025 and the final diagnostic performance of Triage Plus will be presented at USANZ 2026. Conclusion(s): The study results will assess the diagnostic performance of Cxbladder Triage Plus as a urinary diagnostic assay for patients presenting with haematuria in routine clinical practice.