血尿患者におけるCxbladder Triageの臨床的有用性：マッチドコホート研究

To evaluate real-world utility of adding Cxbladder Triage test to microhematuria diagnostic workflow in an integrated healthcare system.

We conducted a retrospective matched cohort study of microhematuria patients tested with Cxbladder Triage, a urine-based biomarker of mRNA targets and clinical factors to assess urothelial cancer risk. We matched untested controls based on age, encounter date, and hematuria risk index score. The cohort was stratified by Cxbladder Triage result; low probability (<4.00, cystoscopy could be deferred) vs physician-directed protocol (≥4.00, cystoscopy recommended). We evaluated the use of cystoscopy, CT urograms, and new diagnoses of bladder cancer.

We matched 3,353 patients tested with Cxbladder Triage with 3,353 controls according to American Urological Association (AUA) risk (15.7% AUA low risk for cases and controls, p=0.362). Among 3,353 tested patients, 2,670 (79.6%) had low probability of cancer and were less likely to undergo cystoscopy (3.8% vs 46.5% controls, p<0.001). Tested patients with elevated risk for cancer (n=683) were more likely to undergo cystoscopy (73.4% vs 45.7% controls, p<0.001). Similar patterns were seen for CT urogram (7.5% vs 11.7% low probability; 19.5% vs 13.3% physician-directed protocol, both p<0.001). Cancer detection was similar between both groups (0.3% tested vs 0.6% controls, p=0.105) and between tested patients with elevated risk vs untested controls (1.5% physician-directed protocol vs 0.6% controls, p=0.107).

Cxbladder Triage testing decreases burden of cystoscopy and CT urogram use among microhematuria patients. This test maintains similar cancer detection overall and among microhematuria patients at greater risk for underlying malignancy.