{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T04:43:42Z","timestamp":1783745022823,"version":"3.55.0"},"reference-count":24,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,6,24]],"date-time":"2024-06-24T00:00:00Z","timestamp":1719187200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      To compare Uromonitor\u00ae (U\u2010Monitor Lda, Porto, Portugal), a multitarget DNA assay that detects mutated proto\u2010oncogenes (telomerase reverse transcriptase [\n                      <jats:italic>TERT<\/jats:italic>\n                      ], fibroblast growth factor receptor 3 [\n                      <jats:italic>FGFR\u20103<\/jats:italic>\n                      ], Kirsten rat sarcoma viral oncogene homologue [\n                      <jats:italic>KRAS<\/jats:italic>\n                      ]), with urine cytology in the urine\u2010based diagnosis of urothelial carcinoma of the bladder (UCB) within a multicentre real\u2010world setting.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>This multicentre, prospective, double\u2010blind study was conducted across four German urological centres from 2019 to 2024. We evaluated the diagnostic performance of Uromonitor compared to urine cytology in a cohort of patients with UCB and in healthy controls within a real\u2010world setting. Sensitivity, specificity, positive\u2010predictive value (PPV), negative\u2010predictive value (NPV), and accuracy of the tests were measured, in addition to multivariate analyses to assess the ability of individual proto\u2010oncogene mutations in detecting UCB. The biometric sample size was designed to achieve a 10% difference in sensitivity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Patients with UCB comprised 63.7% (339\/532) of the study group. Uromonitor showed a sensitivity, specificity, PPV, NPV, accuracy, and an area\u2010under\u2010the\u2010curve of 49.3%, 93.3%, 92.8%, 51.1%, 65.2%, and 0.713%, respectively. These metrics did not demonstrate statistical superiority over urine cytology in terms of sensitivity (44.6%;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.316). Moreover, the comparison of additional test parameters, as well as the comparison within various sensitivity analyses, yielded no significant disparity between the two urinary tests. Multivariate logistic regression underscored the significant predictive value of a positive Uromonitor for detecting UCB (odds ratio [OR] 9.03;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001). Furthermore, mutations in\n                      <jats:italic>TERT<\/jats:italic>\n                      and\n                      <jats:italic>FGFR\u20103<\/jats:italic>\n                      were independently associated with high odds of UCB detection (OR 13.30 and 7.04, respectively), while\n                      <jats:italic>KRAS<\/jats:italic>\n                      mutations did not exhibit predictive capability.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Despite its innovative approach, Uromonitor fell short of confirming the superior results anticipated from previous studies in this real\u2010world setting. The search for an optimal urine\u2010based biomarker for detecting and monitoring UCB remains ongoing. Results from this study highlight the complexity of developing non\u2010invasive diagnostic tools and emphasise the importance of continued research efforts to refine these technologies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.16450","type":"journal-article","created":{"date-parts":[[2024,6,24]],"date-time":"2024-06-24T22:54:03Z","timestamp":1719269643000},"page":"992-1000","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Real\u2010world performance of Uromonitor\u00ae in urothelial bladder cancer detection: a multicentric trial"],"prefix":"10.1111","volume":"134","author":[{"given":"Ingmar","family":"Wolff","sequence":"first","affiliation":[{"name":"Department of Urology University Medicine Greifswald  Greifswald Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anton P.","family":"Kravchuk","sequence":"additional","affiliation":[{"name":"Department of Urology St. Elisabeth Hospital Straubing, Brothers of Mercy Hospital  Straubing Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralph M.","family":"Wirtz","sequence":"additional","affiliation":[{"name":"STRATIFYER Molecular Pathology GmbH  Cologne Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thorsten","family":"Schlomm","sequence":"additional","affiliation":[{"name":"Department of Urology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin, Humboldt\u2010Universit\u00e4t zu Berlin, and Berlin Institute of Health  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0124-4878","authenticated-orcid":false,"given":"Anja","family":"Rabien","sequence":"additional","affiliation":[{"name":"Department of Urology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin, Humboldt\u2010Universit\u00e4t zu Berlin, and Berlin Institute of Health  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dezhi","family":"Rong","sequence":"additional","affiliation":[{"name":"Department of Urology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin, Humboldt\u2010Universit\u00e4t zu Berlin, and Berlin Institute of Health  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian L.","family":"Hofbauer","sequence":"additional","affiliation":[{"name":"Department of Urology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin, Humboldt\u2010Universit\u00e4t zu Berlin, and Berlin Institute of Health  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flora K.","family":"Labont\u00e9","sequence":"additional","affiliation":[{"name":"Department of Urology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin, Humboldt\u2010Universit\u00e4t zu Berlin, and Berlin Institute of Health  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitri","family":"Barski","sequence":"additional","affiliation":[{"name":"Department of Urology Rheinland Clinic Neuss  Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Otto","sequence":"additional","affiliation":[{"name":"Department of Urology Rheinland Clinic Neuss  Neuss Germany"},{"name":"Medical School University of Duisburg\u2010Essen  Essen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"G\u00f6ssl","sequence":"additional","affiliation":[{"name":"Department of Urology Rheinland Clinic Neuss  Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine D.","family":"Brookman\u2010May","sequence":"additional","affiliation":[{"name":"Department of Urology University of Munich, LMU  Munich Germany"},{"name":"Johnson and Johnson Innovative Medicine, Research &amp; Development  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian P.","family":"Gilfrich","sequence":"additional","affiliation":[{"name":"Department of Urology St. Elisabeth Hospital Straubing, Brothers of Mercy Hospital  Straubing Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thorsten H.","family":"Ecke","sequence":"additional","affiliation":[{"name":"Department of Urology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin, Humboldt\u2010Universit\u00e4t zu Berlin, and Berlin Institute of Health  Berlin Germany"},{"name":"Department of Urology Helios Hospital  Bad Saarow Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3896-0405","authenticated-orcid":false,"given":"Matthias","family":"May","sequence":"additional","affiliation":[{"name":"Department of Urology St. Elisabeth Hospital Straubing, Brothers of Mercy Hospital  Straubing Germany"},{"name":"Teaching Hospital of the University Clinic Regensburg Chair of Urology at the Caritas St. Josef Medical Center  Regensburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,6,24]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2018.02.014"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000003846"},{"key":"e_1_2_12_5_1","unstructured":"EAU Guidelines.Edn. presented at the EAU Annual Congress Paris 2024. 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