RT Journal Article SR Electronic T1 Gene Expression Signature in Urine for Diagnosing and Assessing Aggressiveness of Bladder Urothelial Carcinoma JF Clinical Cancer Research JO Clin Cancer Res FD American Association for Cancer Research SP 2624 OP 2633 DO 10.1158/1078-0432.CCR-09-3373 VO 16 IS 9 A1 Mengual, Lourdes A1 Burset, Moisès A1 Ribal, María José A1 Ars, Elisabet A1 Marín-Aguilera, Mercedes A1 Fernández, Manuel A1 Ingelmo-Torres, Mercedes A1 Villavicencio, Humberto A1 Alcaraz, Antonio YR 2010 UL http://clincancerres.aacrjournals.org/content/16/9/2624.abstract AB Purpose: To develop an accurate and noninvasive method for bladder cancer diagnosis and prediction of disease aggressiveness based on the gene expression patterns of urine samples.Experimental Design: Gene expression patterns of 341 urine samples from bladder urothelial cell carcinoma (UCC) patients and 235 controls were analyzed via TaqMan Arrays. In a first phase of the study, three consecutive gene selection steps were done to identify a gene set expression signature to detect and stratify UCC in urine. Subsequently, those genes more informative for UCC diagnosis and prediction of tumor aggressiveness were combined to obtain a classification system of bladder cancer samples. In a second phase, the obtained gene set signature was evaluated in a routine clinical scenario analyzing only voided urine samples.Results: We have identified a 12+2 gene expression signature for UCC diagnosis and prediction of tumor aggressiveness on urine samples. Overall, this gene set panel had 98% sensitivity (SN) and 99% specificity (SP) in discriminating between UCC and control samples and 79% SN and 92% SP in predicting tumor aggressiveness. The translation of the model to the clinically applicable format corroborates that the 12+2 gene set panel described maintains a high accuracy for UCC diagnosis (SN = 89% and SP = 95%) and tumor aggressiveness prediction (SN = 79% and SP = 91%) in voided urine samples.Conclusions: The 12+2 gene expression signature described in urine is able to identify patients suffering from UCC and predict tumor aggressiveness. We show that a panel of molecular markers may improve the schedule for diagnosis and follow-up in UCC patients. Clin Cancer Res; 16(9); 2624–33. ©2010 AACR.