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JU INSIGHT Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria

By: Yair Lotan, MD, University of Texas Southwestern Medical Center at Dallas; Siamak Daneshmand, MD, Institute of Urology, University of Southern California Norris Comprehensive Cancer Center, Los Angeles; Neal Shore, MD, Carolina Urologic Research Center, Myrtle Beach, South Carolina; Peter Black, MD, University of British Columbia, Vancouver, Canada; Kristen R. Scarpato, MD, Vanderbilt University Medical Center, Nashville, Tennessee; Amit Patel, MD, DuPage Medical Group, Chicago, Illinois; Tony Lough, PhD, Pacific Edge Ltd, Dunedin, New Zealand; Daniel A. Shoskes, MD, Pacific Edge Diagnostics, Redwood City, California; Jay D. Raman, MD, Penn State Health, Hershey, Pennsylvania | Posted on: 17 Jul 2024

Lotan Y, Daneshmand S, Shore N, et al. A multicenter prospective randomized controlled trial comparing Cxbladder Triage to cystoscopy in patients with microhematuria: the Safe Testing of Risk for Asymptomatic Microhematuria trial. J Urol. 2024;212(1):41-51. doi:10.1097/JU.0000000000003991

Study Need and Importance

Hematuria evaluation is recommended for most patients with microhematuria but compliance with recommendations is low, potentially delaying or missing diagnosis of bladder cancer. We hypothesized that a urinary biomarker with a high sensitivity/negative predictive value, Cxbladder Triage (CxbT), could triage patients who need evaluation by identifying those at high risk and reducing evaluation in low-risk patients with negative marker.

What We Found

Patients included in the study (Figure) were classified according to our criteria into lower risk (LR; 3-29 red blood cells/high-power field and smoking <10 pack-years) and not low-risk patients (>29 red blood cells/high-power field and/or smoking >10 pack-years). LR patients were randomized into marker-based and standard of care (SOC) arms. Of 390 eligible patients who enrolled into the study, 135 were LR randomized to CxbT-informed decision or SOC. In the LR arm, cystoscopy was performed in 67% of SOC and 27% in the marker group (relative risk 0.41, 95% CI 0.27-0.61) resulting in a 59% decrease. Compared to cystoscopy, CxbT had 90% sensitivity, 56% specificity, and 99% negative predictive value for urothelial cancer.

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Figure. Diagram for lower-risk patients used in clinical utility analysis. CxbT indicates Cxbladder Triage; QC, quality control.

Limitations

Limitations included inability to follow-up the entire cohort of patients in LR group, impacting the ability to assess the long-term effects of the decision. Additionally, as the study was designed prior to 2020, our risk stratification did not align with the current 2020 AUA microhematuria guideline. Indeed, many of our LR patients would be intermediate or even high risk (based on age alone) in the current guidelines.

Interpretation for Patient Care

In this prospective randomized controlled trial, use of CxbT in patients with LR hematuria resulted in a 59% relative reduction of cystoscopy use. This clinical utility of CxbT can reduce the burden of unnecessary cystoscopies and thus improve overall patient care.

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