Pd43-05 dna methylation urine biomarkers test (epicheck® assay) in the diagnosis of upper tract urothelial carcinoma: results from a single-center prospective study

You have accessJournal of UrologyBladder Cancer: Upper Tract Transitional Cell Carcinoma I (PD43)1 Sep 2021PD43-05 DNA METHYLATION URINE BIOMARKERS TEST (EPICHECK® ASSAY) IN THE DIAGNOSIS OF UPPER TRACT UROTHELIAL CARCINOMA: RESULTS FROM A SINGLE-CENTER PROSPECTIVE STUDY Andrea Gallioli, Matteo Fontana, Roman Boissier, Angelo Territo, Pietro Diana, Alberto Piana, Christian Martinez, Antoni Sánchez-Puy, Jose Daniel Subiela, Francesco Sanguedolce, Josep Maria Gaya, Joan Palou, and Alberto Breda Andrea GallioliAndrea Gallioli More articles by this author , Matteo FontanaMatteo Fontana More articles by this author , Roman BoissierRoman Boissier More articles by this author , Angelo TerritoAngelo Territo More articles by this author , Pietro DianaPietro Diana More articles by this author , Alberto PianaAlberto Piana More articles by this author , Christian MartinezChristian Martinez More articles by this author , Antoni Sánchez-PuyAntoni Sánchez-Puy More articles by this author , Jose Daniel SubielaJose Daniel Subiela More articles by this author , Francesco SanguedolceFrancesco Sanguedolce More articles by this author , Josep Maria GayaJosep Maria Gaya More articles by this author , Joan PalouJoan Palou More articles by this author , and Alberto BredaAlberto Breda More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002057.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The diagnosis and risk stratification of upper urinary tract urothelial carcinoma (UTUC) can be challenging. Urinary cytology (UC) has low sensitivity and CT scan is not sufficient as in about 50% of cases ureteroscopy (URS) changes treatment choice. Bladder EpiCheck® (Nucleix, Israel) is an innovative assay able to detect a panel of epigenetic DNA methylation patterns found in urothelial cancer cells, especially in high-grade diseases. Our aim is to evaluate the performance of this assay in the detection of UTUC. METHODS: We prospectively enrolled patients undergoing URS at our center between 01/2019 and 01/2021 for the diagnosis, treatment or follow-up of UTUC. Patients with synchronous BC were excluded from the study. We retrieved 20 mL urine samples both from the lower and upper tract, respectively by bladder or ileal conduit and ureteral catheterization for EpiCheck® and UC analysis. Flexible URS was carried out according to standard technique. Test performance was evaluated by sensitivity, specificity, positive (PPV), and negative predictive values (NPV), both for any-grade and high-grade disease. The study (NCT04702347) was approved by the Ethical committee (C2018/35). RESULTS: We enrolled 80 consecutive patients for a total of 87 URS. 2 patients were excluded from the analysis because synchronous BC, while 5 samples resulted unsuitable for epigenetic testing. Overall, we retrieved 72 and 82 valid samples from lower and upper tract respectively (Table 1). Lower tract Sensitivity and NPV for any-grade disease are 58.5% and 80.0% vs 30% and 85.7% in EpiCheck® vs UC; sensitivity and NPV for high grade disease are 73.7% and 88.1% vs 64.4% and 82.7% in EpiCheck® vs UC. Upper tract sensitivity and NPV for any-grade disease are 84.8% and 80.6% vs 52.2% and 60% in EpiCheck® vs UC; sensitivity and NPV for high grade disease are 95.8% and 97.2% vs 64% and 83.6% in EpiCheck® vs UC. CONCLUSIONS: EpiCheck® appears to be a useful tool in the UTUC setting and it could find a crucial role in the diagnosis and follow-up of UTUC, particularly in detecting the absence of a high-grade disease. As EpiCheck® results are remarkable, this assay is now included in the diagnostic work-up of UTUC at our center. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e732-e732 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andrea Gallioli More articles by this author Matteo Fontana More articles by this author Roman Boissier More articles by this author Angelo Territo More articles by this author Pietro Diana More articles by this author Alberto Piana More articles by this author Christian Martinez More articles by this author Antoni Sánchez-Puy More articles by this author Jose Daniel Subiela More articles by this author Francesco Sanguedolce More articles by this author Josep Maria Gaya More articles by this author Joan Palou More articles by this author Alberto Breda More articles by this author Expand All Advertisement PDF downloadLoading ...