An up-to-date catalog of available urinary biomarkers for the surveillance of non-muscle invasive bladder cancer

Soria, Francesco; Droller, Michael J.; Lotan, Yair; Gontero, Paolo; D’Andrea, David; Gust, Kilian M.; Rouprêt, Morgan; Babjuk, Marek; Palou, Joan; Shariat, Shahrokh F.

doi:10.1007/s00345-018-2380-x

Cited by 109 publications

(93 citation statements)

References 105 publications

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“…As an alternative technique to the current diagnosis pattern, the FISH assay has been reported to be a promising tool for diagnosing and surveilling in BC [32]. Compared to invasive methods, such as cystoscopy and TURBT, the FISH assay possesses advantages, including noninvasiveness, comfort and safety, since performing this assay only needs to collect urine samples from patients [9,33].…”

Section: Discussionmentioning

confidence: 99%

Association of chromosome 7 aneuploidy measured by fluorescence in situ hybridization assay with muscular invasion in bladder cancer

Diao

Cai

Zheng

et al. 2020

Cancer Communications

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Background: The preoperative prediction of muscular invasion status is important for adequately treating bladder cancer (BC) but nevertheless, there are some existing dilemmas in the current preoperative diagnostic accuracy of BC with muscular invasion. Here, we investigated the potential association between the fluorescence in situ hybridization (FISH) assay and muscular invasion among patients with BC.A cytogenetic-clinical nomogram for the individualized preoperative differentiation of muscle-invasive BC (MIBC) from non-muscle-invasive BC (NMIBC) is also proposed. Methods: All eligible BC patients were preoperatively tested using a FISH assay, which included 4 sites (chromosome-specific centromeric probe [CSP] 3, 7, and 17, and gene locus-specific probe [GLP]-p16 locus). The correlation between the FISH assay and BC muscular invasion was evaluated using the Chi-square tests. In the training set, univariate and multivariate logistic regression analyses were used to develop a cytogenetic-clinical nomogram for preoperative muscular invasion prediction. Then, we assessed the performance of the nomogram in the training set with respect to its discriminatory accuracy and calibration for predicting muscular invasion, and clinical Abbreviations: AUC, area under the curve; BC, bladder cancer; CI, confidence interval; CSP, chromosome-specific centromeric probe; CT, computed tomography; DCA, decision curve analysis; FISH, fluorescence in situ hybridization; FITC, fluorescein isothiocyanate; GLP, gene locus-specific probe; MIBC, muscle-invasive bladder cancer; MRI, magnetic resonance imaging; NMIBC, non-muscle-invasive bladder cancer; OR, odds ratio; RBC, red blood cell; RC, radical cystectomy; ROC, receiver operator characteristic; TURBT, transurethral resection of bladder tumor.This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

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Section: Discussionmentioning

confidence: 99%

Association of chromosome 7 aneuploidy measured by fluorescence in situ hybridization assay with muscular invasion in bladder cancer

Diao

Cai

Zheng

et al. 2020

Cancer Communications

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“…Several studies have proposed replacing or alternating follow‐up cystoscopies with urinary biomarkers, but none of the tests to date could reach sufficient diagnostic accuracy to reliably replace cystoscopy as the reference standard . A recent up‐to‐date catalogue summarizes the performance of panels as well as single urinary biomarkers in the surveillance of NMIBC . None of these tests achieved a diagnostic accuracy comparable to the Bladder EpiCheck.…”

Section: Discussionmentioning

confidence: 99%

Diagnostic accuracy, clinical utility and influence on decision‐making of a methylation urine biomarker test in the surveillance of non‐muscle‐invasive bladder cancer

et al. 2019

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ObjectivesTo investigate prospectively the clinical utility and influence on decision-making of Bladder EpiCheck TM , a non-invasive urine test, in the surveillance of non-muscle-invasive bladder cancer (NMIBC). Materials and MethodsUrine samples from 440 patients undergoing surveillance for NMIBC were prospectively collected at five centres and evaluated using the Bladder EpiCheck test (NCT02647112). A multivariable nomogram and decision-curve analysis (DCA) were used to evaluate the impact of Bladder EpiCheck on decision-making when used in routine clinical practice. The test was designed to exclude recurrent disease. ResultsData from 357 patients were available for analysis. The test had a specificity of 88% (95% confidence interval [CI] 84-91), a negative predictive value (NPV) of 94.4% (95% CI 91-97) for the detection of any cancer and an NPV of 99.3% for the detection of high-grade cancer. In multivariable analysis, positive Bladder EpiCheck results were independently associated with any and high-grade disease recurrence (odds ratio [OR] 18.1, 95% CI 8.7-40.2; P < 0.001 and OR 78.3, 95% CI 19.2-547; P < 0.001). The addition of Bladder EpiCheck to standard variables improved its predictive ability for any and high-grade disease recurrence by a difference of 16% and 22%, respectively (area under the curve 85.9% and 96.1% for any and high-grade cancer, respectively). DCA showed an improvement in the net benefit relative to cystoscopy over a large threshold of probability, resulting in a significant reduction in unnecessary investigations. These results were similar in subgroups assessing the impact of specific clinical features. ConclusionsBladder EpiCheck is a robust high-performing diagnostic test in patients with NMIBC undergoing surveillance that can potentially reduce the number of unnecessary investigations.

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“…Some of these tests underwent clinical validation and obtained FDA approval. From the FDA-approved tests, urinary cytology, nuclear matrix protein 22 (NMP22) kit, NMP22 BladderChek Test, BTA-TRAK and BTA stat kits, Cell Search, and UroVysion are approved for initial detection and surveillance of BC whereas some tests, such as uCyt +, are only approved for the follow-up of BC [43]. Despite not having FDA approval, other tests exist, and some with European Conformity Approval (CE) marking such as Epicheck and Uromonitor, present promising sensitivity and specificity values.…”

Section: Biomarkers For Bladder Cancer Diagnosis and Follow-up (Currementioning

confidence: 99%

“…All these tests contribute to a diverse choice and demonstrate the efforts to generate a test that will improve patients' life quality. A brief description of the FDA-and CE-approved tests and values for the sensitivity and specificity presented by the manufactures of each kit are available in Table 1. uCyt +, are only approved for the follow-up of BC [43]. Despite not having FDA approval, other tests exist, and some with European Conformity Approval (CE) marking such as Epicheck and Uromonitor, present promising sensitivity and specificity values.…”

Section: Biomarkers For Bladder Cancer Diagnosis and Follow-up (Currementioning

confidence: 99%

Biomarkers for Bladder Cancer Diagnosis and Surveillance: A Comprehensive Review

et al. 2020

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Bladder cancer (BC) ranks as the sixth most prevalent cancer in the world, with a steady rise in its incidence and prevalence, and is accompanied by a high morbidity and mortality. BC is a complex disease with several molecular and pathological pathways, thus reflecting different behaviors depending on the clinical staging of the tumor and molecular type. Diagnosis and monitoring of BC is mainly performed by invasive tests, namely periodic cystoscopies; this procedure, although a reliable method, is highly uncomfortable for the patient and it is not exempt of comorbidities. Currently, there is no formal indication for the use of molecular biomarkers in clinical practice, even though there are several tests available. There is an imperative need for a clinical non-invasive testing for early detection, disease monitoring, and treatment response in BC. In this review, we aim to assess and compare different tests based on molecular biomarkers and evaluate their potential role as new molecules for bladder cancer diagnosis, follow-up, and treatment response monitoring.

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An up-to-date catalog of available urinary biomarkers for the surveillance of non-muscle invasive bladder cancer

Abstract: Current commercially available urinary biomarker-based tests are not sufficiently validated to be widely used in clinical practice. Several novel biomarkers are currently under investigation. Prospective multicenter analyses will be needed to establish their clinical relevance and value.

Cited by 109 publications

References 105 publications

Association of chromosome 7 aneuploidy measured by fluorescence in situ hybridization assay with muscular invasion in bladder cancer

Association of chromosome 7 aneuploidy measured by fluorescence in situ hybridization assay with muscular invasion in bladder cancer

Diagnostic accuracy, clinical utility and influence on decision‐making of a methylation urine biomarker test in the surveillance of non‐muscle‐invasive bladder cancer

Biomarkers for Bladder Cancer Diagnosis and Surveillance: A Comprehensive Review

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