Abstract 2740: Increased accuracy of TRAP-FISH combination in bladder cancer diagnosis in symptomatic patients

Abstract

Abstract Introduction: Previous case-control studies have shown the importance of urine telomerase activity determined by the telomerase repeat amplification protocol (TRAP) assay to detect early bladder cancer. However, its validation is needed in large and consecutive series of symptomatic patients before it can be considered for routine clinical use. The aim of the present study was to verify whether a multiple approach based on first-level TRAP assay analysis and successive evaluation with UroVysion test, limited to patients with TRAP-positive urine samples, could unmask false-positive results and improve diagnostic specificity. Patients and methods: Three hundred individuals with urinary tract symptomatology (50 females, 250 males), but without prior history of bladder malignancy were consecutively enrolled between January 2007 and June 2008. All urine samples were processed for cytological examination and also for telomerase activity determination using a quantitative TRAP assay. FISH analysis was carried out only in TRAP-positive samples. Results: At a cut-off of 50 arbitrary enzymatic units (AEUs), shown in previous case control-studies as the most accurate diagnostic discriminant, the positive predictive value (PPV) and negative predictive value (NPV) using TRAP assay were 48% and 86%, respectively, with an overall accuracy of 71%. With the two-step TRAP-FISH approach, PPV increased to 75% and overall accuracy to 83%. Conclusion: Our results indicate that TRAP assay by itself could make a valid contribution to early bladder cancer diagnosis in high-risk patients with urinary tract symptomatology, and that its combination with FISH could improve specificity by unmasking false-positive TRAP results. *Contributed equally to this work Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 101st Annual Meeting of the American Association for Cancer Research; 2010 Apr 17-21; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2010;70(8 Suppl):Abstract nr 2740.