Background: It was the aim of this study to evaluate the serum levels of cathepsin D (Cath D) as a diagnostic tool in patients with renal cell carcinoma (RCC) in comparison with healthy volunteers. Methods: Cath D serum levels were measured in serum samples obtained preoperatively from 32 patients with histologically confirmed RCC versus 30 healthy individuals using an enzyme immunoassay. Additionally, for the tumor group, Cath D serum levels were correlated with tumor stage and grade as determined according to the 2002 TNM classification. Results: The serum Cath D concentration was not significantly different in patients with RCC compared with healthy individuals (mean 16.58 vs. 16.64 ng/ml; p = 0.43). Furthermore, there was no significant association between Cath D serum levels and several patient or tumor characteristics such as tumor stage, tumor grade, lymph node status, presence of metastasis, gender or age. Conclusions: In contrast to overexpression of Cath D in primary RCC tissue, serum Cath D is not altered in RCC patients when compared with healthy volunteers. In this small cohort, Cath D serum levels did not reveal additional clinical information in patients diagnosed with a small renal mass. Further prospective multicenter studies might shed more light on the value of Cath D in the diagnostics of RCC.

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