Nuclear matrix protein‐22: a prospective evaluation in a population at risk for bladder cancer. Results from the UroScreen study

Study Type – Diagnostic (non‐consecutive cohort without consistently applied reference standard) Level of Evidence 3b What's known on the subject? and What does the study add? The prognosis of bladder cancer significantly depends on tumour stage and time of diagnosis so early diagnosis is desir...

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Published in:BJU international 2012-09, Vol.110 (5), p.699-708
Main Authors: Huber, Severine, Schwentner, Christian, Taeger, Dirk, Pesch, Beate, Nasterlack, Michael, Leng, Gabriele, Mayer, Thomas, Gawrych, Katarzyna, Bonberg, Nadin, Pelster, Martin, Johnen, Georg, Bontrup, Heike, Wellhäußer, Harald, Bierfreund, Hans‐Georg, Wiens, Christian, Bayer, Christian, Eberle, Friedhelm, Scheuermann, Bernd, Kluckert, Mattias, Feil, Gerhard, Brüning, Thomas, Stenzl, Arnulf
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Amines - toxicity
Biological and medical sciences
Biomarkers, Tumor - urine
Bladder cancer
Carcinogens
Cellular biology
Confidence intervals
early detection
Early Detection of Cancer - methods
Environmental Exposure
haematuria
Health risk assessment
Hematuria - etiology
Humans
Medical sciences
Middle Aged
Nephrology. Urinary tract diseases
NMP22
Nuclear Proteins - urine
Prospective Studies
renal function
Risk Factors
Tumors of the urinary system
Urinary Bladder Neoplasms - chemically induced
Urinary Bladder Neoplasms - diagnosis
Urinary system involvement in other diseases. Miscellaneous
Urinary tract. Prostate gland
Urine
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Summary:Study Type – Diagnostic (non‐consecutive cohort without consistently applied reference standard) Level of Evidence 3b What's known on the subject? and What does the study add? The prognosis of bladder cancer significantly depends on tumour stage and time of diagnosis so early diagnosis is desirable to decrease mortality and treatment costs. The NMP22 test is approved for clinical application by the Food and Drug Administration (FDA) of the US. Previous studies have reported values of 47–100% for sensitivity and 58–91% for specificity with this test, but there is no new data on the predictive value of NMP22 for screening bladder cancer (BC). The most important risk factor for BC is the tobacco consumption but occupational exposure to carcinogenic substances, especially aromatic amines, is regarded as another risk factor. The UroScreen study is a prospective longitudinal study for the early detection of BC. To our knowledge, it is the largest prospective validation study conducted over the longest period of time. The study results led us to conclude that, based on the currently available data, NMP22 should not be regarded as an alternative to endoscopy, and we could not make a general recommendation for screening or follow‐up. The UroScreen results indicate that urine‐based molecular markers could be a suitable addition to urine cytology and the detection of microhaematuria. OBJECTIVE •  To evaluate the value of nuclear matrix protein‐22 (NMP22) in bladder cancer (BC) screening, and its effect on variables in a prospective study in a high‐risk population. PATIENTS AND METHODS •  A total of 1772 chemical workers (mean age 62 years) exposed to carcinogenic aromatic amines were enrolled in the study. •  In all, 7091 screening check‐ups in 1609 subjects were performed. •  Urine samples were collected for a quantitative NMP22 immunoassay, urine analysis and creatinine concentration assessment. •  Cystoscopy and subsequent transurethral resection were performed where there were suspicious findings. RESULTS •  Histopathological analysis found three papillary urothelial neoplasms of low malignant potential, five recurrent BCs and 13 primary BCs. Three tumours were at a muscle‐invasive stage (pT2, pT3a or pT3b). •  We found higher NMP22 concentrations (>10 U/mL) in 224 patients, which correctly predicted BC in six cases (sensitivity 97.29%, specificity 28.57%; negative predictive value 99.04%, positive predictive value 12.24%). •  Gross haematuria affected NMP22 resu
ISSN:1464-4096
1464-410X
DOI:10.1111/j.1464-410X.2011.10883.x