Toward noninvasive follow-up of low-risk bladder cancer – Rationale and concept of the UroFollow trial*

Benderska-Söder, Natalya; Hovanec, Jan; Pesch, Beate; Goebell, Peter J.; Roghmann, Florian; Noldus, Joachim; Rabinovich, Juri; Wichert, Katharina; Gleichenhagen, Jan; Käfferlein, Heiko U.; Köhler, Christof; Johnen, Georg; Kernig, Karoline; Hakenberg, Oliver W.; Jahn, Daniela; Todenhöfer, Tilman; Stenzl, Arnulf; Gleißner, Jochen; Gerwert, Klaus; El-Mashtoly, Samir F.; Behrens, Thomas; Brüning, Thomas; Schmitz‐Dräger, Bernd J.

doi:10.1016/j.urolonc.2020.01.006

Cited by 29 publications

(24 citation statements)

References 41 publications

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“…In patients with no previously diagnosed bladder cancer A significant amount of recent biomarker research has been focused on aiding in the surveillance follow-up of known bladder cancers. [26][27][28] Unfortunately, as biomarkers are often highly sensitive and can provide a positive result before it is cystoscopically visible, "anticipatory positive results," the cost effectiveness of combined biomarker-cystoscopy surveillance, have been shown to be worse than cystoscopy alone. 26 Focusing on screening adjunct applications for biomarkers with high sensitivity and NPV, such as URO17™, is more likely to result in them becoming cost efficient and valuable adjuncts to both primary and secondary care.…”

Section: Uro17 Resultsmentioning

confidence: 99%

“…A significant amount of recent biomarker research has been focused on aiding in the surveillance follow‐up of known bladder cancers 26–28 . Unfortunately, as biomarkers are often highly sensitive and can provide a positive result before it is cystoscopically visible, “anticipatory positive results,” the cost effectiveness of combined biomarker‐cystoscopy surveillance, have been shown to be worse than cystoscopy alone 26 .…”

Section: Discussionmentioning

confidence: 99%

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The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

et al. 2020

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Introduction and objectives Novel biomarker research is vital for the progression of safe and thorough diagnostic medicine. There is now a need to improve the diagnosis of bladder cancer via a noninvasive urine test while balancing the risks of harm from investigational procedures, such as cystoscopy and radiological tests, against the likelihood of malignancy. We evaluate the diagnostic accuracy and sensitivity of Uro17™ urinary biomarker for the detection of urothelial cancer in hematuria patients in a prospective blinded validation study. Uro17™ is an immunobiomarker which binds to the oncoprotein Keratin 17, which is involved in the replication cycle of malignant cells. This study compared cystoscopic and histological investigations against Uro17™ results in patients being investigated for symptoms of urothelial cancer. Materials and methods After receiving both local and national ethics/protocol approval, 71 patients were consented and recruited into the study. All patients were scheduled to undergo cystoscopic investigation, and following recruitment, a urine sample was collected. Urine samples were anonymized and processed as per standard cytology protocols and stained using Uro17™ immunobiomarker. The pathologists assessing the results were blinded to the patient and background history, and the results were compared to the biopsy histology. Results The full cohort of enrolled patients consisted of 71 participants included. There were 55 males and 16 females, with an average age of 70. Thirteen were current smokers, 42 ex‐smokers, and 16 nonsmokers. The malignancies detected included both muscle‐invasive (n = 6) and non‐muscle‐invasive tumors (n = 38), and tumors of all grades and carcinoma in situ. Uro17™ was shown to have an overall sensitivity of 100% and a specificity of 92.6%, with a positive predictive value of 0.957 and negative predictive value of 1. Uro17™ investigation was positive in every case of urothelial malignancy. Conclusions Our current data indicates Uro17™ is a highly sensitive noninvasive bladder cancer urine detection test that can improve the diagnosis of Bladder cancer. This can further improve diagnostic capabilities in primary care, reduce the number of referrals to Urology department, and reduce the number of unnecessary invasive procedures for new patients with a suspected urinary bladder cancer.

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Section: Uro17 Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

et al. 2020

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“…Kim et al (2014) reported that being UroVysion-positive could predict the recurrence and progression of BCa in patients with negative cystoscopy and suspicious cytology results, and in those with a non-muscle invasive BCa negative result by cystoscopy (42). A prospective study comparing urinary biomarkers in a followup of patients with non-muscle invasive BCa with a low grade highlighted the superiority of UroVysion to cytology in terms of sensitivity and specificity (43). Consecutive UroVysion testing was reported as a more reliable method in predicting intravesical recurrence after transurethral resection of bladder tumor (TURBT) (15).…”

Section: Bca Surveillance Without Visible Tumorsmentioning

confidence: 99%

UroVysion fluorescence in situ hybridization in urothelial carcinoma: a narrative review and future perspectives

Nagai¹,

Naiki²,

Etani³

et al. 2021

Transl Androl Urol

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“…Both clinicians and companies should make every effort to validate an assay in a prospective trial designed in cooperation with guideline panels and key opinion leaders. One example of a prospective trial that has been set up in a specific setting with a specific hypothesis is the UroFollow trial [83]. In this trial, patients with low grade NMIBC are randomized to receive standard of care surveillance using cystoscopy versus regular measurement of urine markers (including cytology and UroVysion), with cystoscopies performed only in the case of a positive marker or clinical signs of recurrence.…”

Section: Clinical Considerations For Use Of Urinary Molecular Markers In Context Of Bcmentioning

confidence: 99%

Urinary-Based Markers for Bladder Cancer Detection

Todenhöfer¹,

Lodde²,

Kessel³

et al. 2020

Société Internationale D’Urologie Journal

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Background The use of urine markers for diagnosis and surveillance has been a topic of broad interest and ongoing controversies in the management of patients with bladder cancer. There has been a constant quest for markers that demonstrate clinical utility. Aim In the framework of the International Consultation on Urological Diseases 2019 on Molecular Biomarkers in Urologic Oncology, a comprehensive review of literature on urinary biomarkers for bladder cancer has been performed. Results Currently available urinary markers include protein-based markers, RNA-based markers, and DNA-based markers. The introduction of high-throughput analysis technologies provides the opportunity to assess multiple parameters within a short period of time, which is of interest for RNA-based, DNA-based, and protein-based marker systems. A comprehensive analysis of molecular alterations in urine samples of bladder cancer patients may be of interest not only for diagnosis and surveillance but also for non-invasive longitudinal assessment of molecular, potentially therapy-relevant, alterations. However, most systems lack prospective validation within well-designed trials and have not been broadly implemented in daily clinical practice. Conclusions Because of limited data from prospective trials, the routine use of any urine marker except cytology is not considered as standard of care in international guidelines. There is an urgent need for prospective trials of urine markers to answer specific clinical questions.

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Toward noninvasive follow-up of low-risk bladder cancer – Rationale and concept of the UroFollow trial*

Cited by 29 publications

References 41 publications

The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

UroVysion fluorescence in situ hybridization in urothelial carcinoma: a narrative review and future perspectives

Urinary-Based Markers for Bladder Cancer Detection

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