Detection of bladder cancer using a point-of-care proteomic assay

被引:262
|
作者
Grossman, HB
Messing, E
Soloway, M
Tomera, K
Katz, G
Berger, Y
Shen, Y
机构
[1] Univ Texas, MD Anderson Canc Ctr, Dept Urol, Houston, TX 77030 USA
[2] Univ Texas, MD Anderson Canc Ctr, Dept Biostat & Appl Math, Houston, TX 77030 USA
[3] Univ Rochester, Med Ctr, Dept Urol, Rochester, NY 14642 USA
[4] Univ Miami, Sch Med, Dept Urol, Miami, FL USA
[5] Alaska Clin Res Ctr, Anchorage, AK USA
[6] Lake City Vet Adm Hosp, Dept Surg, Urol Serv, Manitowoc, WI USA
[7] LakeShore Urol, Manitowoc, WI USA
[8] Associates Urol, W Orange, NJ USA
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关键词
D O I
10.1001/jama.293.7.810
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Context A combination of methods is used for diagnosis of bladder cancer because no single procedure detects all malignancies. Urine tests are frequently part of an evaluation, but have either been nonspecific for cancer or required specialized analysis at a laboratory. Objective To investigate whether a point-of-care proteomic test that measures the nuclear matrix protein NMP22 in voided urine could enhance detection of malignancy in patients with risk factors or symptoms of bladder cancer. Design, Setting, and Patients Twenty-three academic, private practice, and veterans' facilities in 10 states prospectively enrolled consecutive patients from September 2001 to May 2002. Participants included 1331 patients at elevated risk for bladder cancer due to factors such as history of smoking or symptoms including hematuria and dysuria. Patients at risk for malignancy of the urinary tract provided a voided urine sample for analysis of NMP22 protein and cytology prior to cystoscopy. Main Outcome Measures The diagnosis of bladder cancer, based on cystoscopy with biopsy, was accepted as the reference standard. The performance of the NMP22 test was compared with voided urine cytology as an aid to cancer detection. Testing for the NMP22 tumor marker was conducted in a blinded manner. Results Bladder cancer was diagnosed in 79 patients. The NMP22 assay was positive in 44 of 79 patients with cancer (sensitivity, 55.7%; 95% confidence interval [CI], 44.1%-66.7%), whereas cytology test results were positive in 12 of 76 patients (sensitivity, 15.8%; 95% Cl, 7.6%-24.0%). The specificity of the NMP22 assay was 85.7% (95% Cl, 83.8%-87.6%) compared with 99.2% (95% Cl, 98.7%-99.7%) for cytology. The proteomic marker detected 4 cancers that were not visualized during initial endoscopy, including 3 that were muscle invasive and 1 carcinoma in situ. Conclusion The noninvasive point-of-care assay for elevated urinary NMP22 protein can increase the accuracy of cystoscopy, with test results available during the patient visit.
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页码:810 / 816
页数:7
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