Key result
Enhanced canalicular clusterin staining was observed in 70% of hepatocellular carcinomas but not in regenerative nodules or non-hepatocellular tumors, yielding a diagnostic sensitivity of 0.70 and specificity of 1.00.
Why the study?
Histologic distinction between well differentiated HCC and benign hepatocellular mass lesions is challenging, existing biomarkers have limited value, and the diagnostic utility of clusterin needed further evaluation.
Does clusterin (CLU) immunostaining improve diagnostic accuracy for hepatocellular carcinoma compared to pCEA and CD10?
Observational (n=1,488)
Yes
Does clusterin (CLU) immunostaining improve diagnostic accuracy for hepatocellular carcinoma compared to pCEA and CD10?
Absolute Event Rate: 70% vs 0%
p-value: p=<0.001
Clusterin immunostaining demonstrates high specificity and superior sensitivity compared to pCEA and CD10 for distinguishing well to moderately differentiated HCC from benign lesions and non-HCC malignancies.
Canalicular CLU pattern may aid distinction of well-differentiated HCC from benign lesions; leaves open prospective validation before diagnostic adoption.
Background Histologic distinction between well differentiated hepatocellular carcinoma (HCC) and benign hepatocellular mass lesions is a known challenging. Existing biomarkers are of limited diagnostic value. Our previous studies observed an enhanced canalicular expression pattern of clusterin (CLU) in HCC, which was not observed in benign hepatocellular mass lesions such as hepatocellular adenoma. The aim of this study was to further investigate its diagnostic value for HCC by examining the expression pattern of CLU in a large number of non-hepatocellular tumors, and by comparing it with two other commonly used hepatocellular markers pCEA and CD10 that also show a canalicular staining pattern in HCC. Methods Enhanced canalicular staining patterns of CLU, pCEA and CD10 were analyzed on 54 surgically resected well to moderately differentiated HCCs on whole tissue sections, of which 37 had surrounding regenerative nodules while the remaining 17 had a non-cirrhotic background. CLU immunostaining was also performed on tissue microarray sections that contained 74 HCCs (40 of which were also stained for pCEA and CD10), 55 normal liver tissue samples, and 1305 non-hepatocellular tumors from multiple organs. Results Enhanced CLU canalicular staining was observed in 70% (89/128) HCCs but not in regenerative nodules, normal liver tissues or any non-hepatocellular tumors. The sensitivity and specificity for enhanced canalicular staining pattern of CLU in HCCs were 0.70 and 1.00. This enhanced canalicular pattern was observed in only 26% and 23% HCCs for CD10 and pCEA, respectively. These results further demonstrate that the distinctive enhanced canalicular pattern of CLU is unique to HCC. Conclusions CLU is superior to pCEA and CD10 as a diagnostic immunomarker in that it can help distinguish well to moderately differentiated HCC not only from non-HCC malignancies but also from benign hepatocellular mass lesions.
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Li et al. (2020) conducted an observational in Hepatocellular Carcinoma (n=1,488). Clusterin (CLU) immunostaining vs. pCEA and CD10 immunostaining was evaluated on Enhanced canalicular staining pattern (>10% of cells) in hepatocellular carcinoma versus regenerative nodules (p=<0.001). Enhanced canalicular clusterin staining was observed in 70% of hepatocellular carcinomas but not in regenerative nodules or non-hepatocellular tumors, yielding a diagnostic sensitivity of 0.70 and specificity of 1.00.
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