PT - JOURNAL ARTICLE AU - Mengual, Lourdes AU - Burset, Moisès AU - Ribal, María José AU - Ars, Elisabet AU - Marín-Aguilera, Mercedes AU - Fernández, Manuel AU - Ingelmo-Torres, Mercedes AU - Villavicencio, Humberto AU - Alcaraz, Antonio TI - Gene Expression Signature in Urine for Diagnosing and Assessing Aggressiveness of Bladder Urothelial Carcinoma AID - 10.1158/1078-0432.CCR-09-3373 DP - 2010 May 01 TA - Clinical Cancer Research PG - 2624--2633 VI - 16 IP - 9 4099 - http://clincancerres.aacrjournals.org/content/16/9/2624.short 4100 - http://clincancerres.aacrjournals.org/content/16/9/2624.full SO - Clin Cancer Res2010 May 01; 16 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.