Quantitative detection of human complement factor H-related protein in transitional cell carcinoma of the urinary bladder

Objective: The purpose of th is study was to assess a new quantitative urin ary tumor marker for transitional cell carcinoma of the urinary bladder (TC C), human complement factor H-related protein (hCFHrp, BTA TRAK(TM)). Metho ds: Urine samples of 298 individuals (76 healthy volunteers, 118 patients w ith benign urologic disorders, 104 patients with histologically proven blad der cancer) were examined for the presence of hCFHrp. Samples of all patien ts were obtained prior to therapy. Results: In comparison to healthy volunt eers, patients with TCC had significantly higher urinary levels of hCFHrp ( 117.60 vs. 2.05 U/ml; p < 0.001). HCFHrp levels were positively correlated with tumor grade and stage. Patients with invasive TCC had significantly hi gher levels of hCFHrp than patients with superficial TCC (p = 0.001). Marke r levels in superficial bladder cancer at high risk of tumor progression (p T1G3) were significantly higher as compared to low and intermediate grade s uperficial cancers. Elevated levels of hCFHrp were also found in patients w ith benign urologic disorders (median: 72.65 vs. 117.60 U/ml in cancer pati ents). Using a cutoff of 17.1 U/ml, hCFHrp had a sensitivity of 72.1% and, due to a high rate of false-positive determinations in patients with benign urologic disorders, a total specificity of 50.5%. Conclusions: HCFHrp (BTA TRAK(TM)) is a sensitive test for detection of bladder cancer and for iden tification of patients at high risk. Due to a high rate cf false-positive r esults in patients with benign urologic diseases, the test should not be us ed in an unselected population.