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J Transl Med. 2016 Oct 7;14(1):287.

A multiplex urinary immunoassay for bladder cancer detection: analysis of a Japanese cohort.

Author information

1
Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL, USA.
2
Mayo Clinic Cancer Center, Rochester, MN, USA.
3
Department of Urology, Kyoto University, Kyoto, Japan.
4
Department of Urology, Nara Medical University, Nara, Japan.
5
Department of Biostatistics, The University of Florida, Gainesville, FL, USA.
6
Clinical and Translational Research Program, University of Hawaii Cancer Center, 701 Ilalo St, Rm 327, Honolulu, HI, 96813, USA.
7
Clinical and Translational Research Program, University of Hawaii Cancer Center, 701 Ilalo St, Rm 327, Honolulu, HI, 96813, USA. cjrosser@hawaii.edu.

Abstract

BACKGROUND:

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. 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.

METHODS:

The 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.

RESULTS:

Urinary 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.

CONCLUSIONS:

Urinary 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.

KEYWORDS:

Biomarkers; Bladder cancer; Multiplex; Protein; Urine

PMID:
27717367
PMCID:
PMC5055716
DOI:
10.1186/s12967-016-1043-1
[Indexed for MEDLINE]
Free PMC Article

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