Abstract
BackgroundBladder cancer (BCa) is among the most commonly diagnosed malignancies worldwide, and due the high rate of post-operative disease recurrence, it is one of the most prevalent in many countries. The development of non-invasive molecular assays that can accurately detect and monitor BCa would be a major advance, benefiting both patients and healthcare systems. We have previously identified a urinary protein biomarker panel that is being developed for application in at-risk patient cohorts. Here, we investigated the potential utility of the multiplex assay in a Japanese cohort.MethodsThe Japanese study cohort collected from urology clinics at two institutions was comprised of a total of 288 subjects. The protein biomarker panel (IL8, MMP9, MMP10, ANG, APOE, SDC1, A1AT, PAI1, CA9, VEGFA) was monitored in voided urine samples collected prior to cystoscopy using a custom multiplex ELISA assay. The diagnostic performance of the biomarker panel was assessed using receiver operator curves, predictive modeling and descriptive statistics.ResultsUrinary biomarker concentrations were significantly elevated in cases versus controls, and in cases with high-grade and muscle-invasive tumors. The AUC for the 10-biomarker assay was 0.892 (95 % confidence interval 0.850–0.934), with an overall diagnostic sensitivity specificity of 0.85 and 0.81, respectively. A predictive model trained on the larger institutional cohort correctly identified 99 % of the cases from the second institution.ConclusionsUrinary levels of a 10-biomarker panel enabled discrimination of patients with BCa. The multiplex urinary diagnostic assay has the potential to be developed for the non-invasive detection of BCa in at-risk Japanese patients.
Highlights
Bladder cancer (BCa) is among the most commonly diagnosed malignancies worldwide, and due the high rate of post-operative disease recurrence, it is one of the most prevalent in many countries
In a series of previous studies, we have identified panels of protein biomarkers that are significantly associated with BCa [6, 7]
This retrospective phase II study confirms the potential of using urinary protein biomarker signatures for the non-invasive detection of BCa, and suggests that the described multiplex immunoassay could aid in Japanese urology patient management
Summary
Bladder cancer (BCa) is among the most commonly diagnosed malignancies worldwide, and due the high rate of post-operative disease recurrence, it is one of the most prevalent in many countries. We tested the potential utility of the multiplex immunoassay for the detection of BCa in a Japanese cohort. Evaluation of 288 subjects obtained from two independent institutes confirmed a significant association of the tested biomarkers with the presence of BCa. The multiplex assay achieved a strong overall diagnostic performance achieving 85 % sensitivity and 81 % specificity (AUC 0.892). The multiplex assay achieved a strong overall diagnostic performance achieving 85 % sensitivity and 81 % specificity (AUC 0.892) This retrospective phase II study confirms the potential of using urinary protein biomarker signatures for the non-invasive detection of BCa, and suggests that the described multiplex immunoassay could aid in Japanese urology patient management
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