Qualitative determination of urinary human complement factor H-related protein (hcfHrp) in patients with bladder cancer, healthy controls, and patients with benign urologic disease.
OBJECTIVE
To assess the diagnostic quality of human complement factor H-related protein (hcfHrp, BTA STAT(TM)) as a qualitative urinary marker for bladder cancer.


METHODS
Urine samples of 354 individuals (76 healthy volunteers, 111 patients with benign urologic disorders, 167 patients with histologically proven bladder cancer) were examined prior to therapy for the presence of hcfHrp.


RESULTS
Overall test sensitivity was 62.9%. Sensitivity of low-grade/low-stage tumors was <50% and was thus comparable to published sensitivities of urinary cytology. In high-stage, high-grade tumors sensitivity was 100 and 77.3%, respectively. Superficial tumors with high risk of progression (pT1G3) were detected significantly better (88.9% sensitivity) than low-risk superficial tumors (pTa G1-3/pT1G1-2; 48.2%; p < 0.001). The overall specificity (healthy individuals and patients with benign urologic disease) was 93.0%.


CONCLUSIONS
Since test sensitivity is comparable to urinary cytology and specificity is excellent, hcfHrp should be further evaluated in prospective studies focussing on the follow-up of patients with bladder cancer.
Heicappell
R
R
Department of Urology, Universitätsklinikum Benjamin-Franklin, Freie Universität, Berlin, Germany. heicappell@medizin.fu-berlin.de
Müller
M
M
Fimmers
R
R
Miller
K
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000032:analysis / Q000652:urine*; D002295:Carcinoma, Transitional Cell / Q000175:diagnosis / Q000652:urine*; D017242:Complement Factor H / Q000032:analysis / Q000652:urine*; D016001:Confidence Intervals; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D012680:Sensitivity and Specificity; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis / Q000652:urine*; D014570:Urologic Diseases / Q000175:diagnosis / Q000652:urine
D014408:Biomarkers, Tumor; C493495:CFH protein, human; D017242:Complement Factor H