{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T03:37:25Z","timestamp":1772249845749,"version":"3.50.1"},"reference-count":19,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2015,7,3]],"date-time":"2015-07-03T00:00:00Z","timestamp":1435881600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005640","name":"Flight Attendant Medical Research Institute","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005640","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007313","name":"University of Texas MD Anderson Cancer Center","doi-asserted-by":"publisher","award":["CA016672"],"award-info":[{"award-number":["CA016672"]}],"id":[{"id":"10.13039\/100007313","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2016,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      To present a molecular definition of bacille Calmette\u2010Gu\u00e9rin (BCG) failure that incorporates fluorescence\n                      <jats:italic>in\u00a0situ<\/jats:italic>\n                      hybridization (FISH) testing to predict BCG failure before it becomes clinically evident, which can be used to enhance trial designs for patients with non\u2010muscle\u2010invasive bladder cancer.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>We used data from 143 patients who were followed prospectively for 2\u00a0years during intravesical BCG therapy, during which time FISH assays were collected and correlated to clinical outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of the 95 patients with no evidence of tumour at 3\u2010month cystoscopy, 23 developed tumour recurrence and 17 developed disease progression by 2\u00a0years. Patients with a positive FISH test at both 6\u00a0weeks and 3\u00a0months were more likely to develop tumour recurrence (17\/37 patients [46%] and 16\/28 patients [57%], respectively) than patients with a negative FISH test (6\/58 patients [10%] and 3\/39 patients [8%], respectively; both\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.001). Using hazard ratios for recurrence with positive 6\u2010week and 3\u2010month FISH results, we constructed clinical trial scenarios whereby patients with a negative 3\u2010month cystoscopy and positive FISH result could be considered to have \u2018molecular BCG failure\u2019 and could be enrolled in prospective, randomized clinical trials comparing BCG therapy (control) with an experimental intravesical therapy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Patients with positive early FISH and negative 3\u2010month cystoscopy results can be considered to have molecular BCG failure based on their high rates of recurrence and progression. This definition is intended for use in designing clinical trials, thus potentially allowing continued use of BCG as an ethical comparator arm.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.13186","type":"journal-article","created":{"date-parts":[[2015,6,1]],"date-time":"2015-06-01T02:53:49Z","timestamp":1433127229000},"page":"754-760","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":36,"title":["Novel fluorescence\n                    <i>in\u00a0situ<\/i>\n                    hybridization\u2010based definition of bacille Calmette\u2010Gu\u00e9rin (BCG) failure for use in enhancing recruitment into clinical trials of intravesical therapies"],"prefix":"10.1111","volume":"117","author":[{"given":"Ashish M.","family":"Kamat","sequence":"first","affiliation":[{"name":"Department of Urology University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel L.","family":"Willis","sequence":"additional","affiliation":[{"name":"Department of Urology University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rian J.","family":"Dickstein","sequence":"additional","affiliation":[{"name":"Department of Urology University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rooselvelt","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Urology University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Graciela","family":"Nogueras\u2010Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruth L.","family":"Katz","sequence":"additional","affiliation":[{"name":"Department of Cytopathology University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xifeng","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Epidemiology University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H.","family":"Barton Grossman","sequence":"additional","affiliation":[{"name":"Department of Urology University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Colin P.","family":"Dinney","sequence":"additional","affiliation":[{"name":"Department of Urology University of Texas MD Anderson Cancer Center Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,7,3]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2011.03.017"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2011.07.076"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410x.1998.00628.x"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/0959-8049(95)00287-S"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2007.09.003"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2012.08.061"},{"key":"e_1_2_7_8_1","unstructured":"National Comprehensive Cancer Network.NCCN Guidelines for Bladder Cancer Version 2.2012. Available at:http:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/bladder.pdf. Accessed March 2013"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)64273-5"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2011.10.144"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2005.12.031"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)67707-5"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncy.20099"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)65756-4"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2011.05.045"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2003.10.006"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2012.11.023"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2012.10.039"},{"key":"e_1_2_7_19_1","first-page":"882","article-title":"Accuracy of grading of urothelial carcinoma on urine cytology: an analysis of interobserver and intraobserver agreement","volume":"5","author":"Reid MD","year":"2012","journal-title":"Int J Clin Exp Pathol"},{"key":"e_1_2_7_20_1","article-title":"Multicenter evaluation of the role of UroVysion FISH assay in surveillance of patients with bladder cancer: does FISH positivity anticipate recurrence?","author":"Seideman C","year":"2014","journal-title":"World J Urol"}],"container-title":["BJU International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fbju.13186","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bju.13186","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T14:27:50Z","timestamp":1761748070000},"score":1,"resource":{"primary":{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/10.1111\/bju.13186"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,7,3]]},"references-count":19,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2016,5]]}},"alternative-id":["10.1111\/bju.13186"],"URL":"https:\/\/doi.org\/10.1111\/bju.13186","archive":["Portico"],"relation":{},"ISSN":["1464-4096","1464-410X"],"issn-type":[{"value":"1464-4096","type":"print"},{"value":"1464-410X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,7,3]]},"assertion":[{"value":"2015-07-03","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}