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Scale-Up Evaluation of a Composite Tumor Marker Assay for the Early Detection of Renal Cell Carcinoma

 Dong Su Kim  ;  Won Sik Ham  ;  Won Sik Jang  ;  Kang Su Cho  ;  Young Deuk Choi  ;  Suki Kang  ;  Bora Kim  ;  Kook Jin Kim  ;  Eun Ji Lim  ;  Sun Young Rha  ;  Ja Hyeon Ku  ;  Cheol Kwak  ;  Hyeon Hoe Kim  ;  Chang Wook Jeong  ;  Nam Hoon Cho 
 DIAGNOSTICS, Vol.10(10) : E750, 2020-09 
Journal Title
Issue Date
biomarker ; diagnosis ; multiplexed immunoassay ; renal cell carcinoma
The early detection of renal cell carcinoma (RCC) using tumor markers remains an attractive prospect for the potential to downstage the disease. To validate the scale-up clinical performance of potential tumor markers for RCC (as a single marker and as a composite tumor marker composed of nicotinamide N-methyltransferase (NNMT), L-Plastin (LCP1), and non-metastatic cells 1 protein (NM23A)), the scale-up assay was performed. Patients with RCC from multiple domestic institutes were included in the clinical evaluation for reassessment and improvement of the established triple markers of our product. For the diagnostic performance of the composite markers, the best-split cutoff points of each marker (147 pg/mL for NNMT, 1780 pg/mL for LCP1, and 520 pg/mL for NM23A) were installed. Serum levels of NNMT, LCP1, and NM23A were greatly increased in subjects with RCC (p < 0.0001). In 1042 blind sample tests with control individuals (n = 500) and patients with RCC (n = 542), the diagnostic sensitivity and specificity of the composite three-marker assay were 0.871 and 0.894, respectively, and the resulting AUC (Area under Curve) of ROC (Receiver Operating Characteristic) was 0.917. As a single marker, the diagnostic accuracies of NNMT, LCP1, and NM23A, as estimated by ROC, were 0.833, 0.844, and 0.601, respectively. The composite three-marker assay with NNMT, LCP1, and NM23A is a more improved novel serum marker assay for the early detection of RCC in cases of renal mass or unknown condition. The NNMT, LCP1, and NM23A triple marker assay could be a powerful diagnostic tumor marker assay to screen the early stage of RCC.
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1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
Kang, Suki(강숙희) ORCID logo https://orcid.org/0000-0002-9957-3479
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
Jang, Won Sik(장원식) ORCID logo https://orcid.org/0000-0002-9082-0381
Cho, Kang Su(조강수) ORCID logo https://orcid.org/0000-0002-3500-8833
Cho, Nam Hoon(조남훈) ORCID logo https://orcid.org/0000-0002-0045-6441
Choi, Young Deuk(최영득) ORCID logo https://orcid.org/0000-0002-8545-5797
Ham, Won Sik(함원식) ORCID logo https://orcid.org/0000-0003-2246-8838
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