The Role of New Technologies in the Diagnosis and Surveillance of Non-Muscle Invasive Bladder Carcinoma: A Prospective, Double-Blinded, Monocentric Study of the XPERT© Bladder Cancer Monitor and Narrow Band Imaging© Cystoscopy

Singer, Gad; Ramakrishnan, Venkat M.; Rogel, Uwe; Schötzau, Andreas; Disteldorf, Daniel; Maletzki, Philipp; Adank, Jean-Pascal; Hofmann, M.; Niemann, Tilo; Stadlmann, Sylvia; Nocito, Antonio; Lehmann, Kurt; Hefermehl, Lukas

doi:10.3390/cancers14030618

Cited by 11 publications

(9 citation statements)

References 37 publications

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“…Oncuria™, a multiplex immunoassay, was used to detect bladder performance in urine in a multi-institutional cohort study. For a total of 362 prospectively collected subjects evaluated for BCa, Oncuria™ had an overall sensitivity of 93%, specificity of 93%, PPV of 65%, and NPV of 99% [61].…”

Section: Proteinsmentioning

confidence: 99%

“…The sensitivity, specificity, PPV, and NPV of another urinary biomarker test for XPERT© Bladder Cancer Monitor were 72% (95% CI: 0.63-0.80), 76% (95% CI: 0.72-0.81), 43% (95% CI: 0.32-0.54), and 92% (95% CI: 0.90-0.90), respectively [69]. A prospective study from Singer et al noted that the XPERT© Bladder Cancer Monitor might provide better sensitivity in the case of high-grade NMIBC recurrence [61].…”

Section: Genomic Biomarkersmentioning

confidence: 99%

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Advances in Diagnosis and Therapy for Bladder Cancer

2022

Cancers

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Bladder cancer (BCa) is one of the most common and expensive urinary system malignancies for its high recurrence and progression rate. In recent years, immense amounts of studies have been carried out to bring a more comprehensive cognition and numerous promising clinic approaches for BCa therapy. The development of innovative enhanced cystoscopy techniques (optical techniques, imaging systems) and tumor biomarkers-based non-invasive urine screening (DNA methylation-based urine test) would dramatically improve the accuracy of tumor detection, reducing the risk of recurrence and progression of BCa. Moreover, intravesical instillation and systemic therapeutic strategies (cocktail therapy, immunotherapy, vaccine therapy, targeted therapy) also provide plentiful measures to break the predicament of BCa. Several exploratory clinical studies, including novel surgical approaches, pharmaceutical compositions, and bladder preservation techniques, emerged continually, which are supposed to be promising candidates for BCa clinical treatment. Here, recent advances and prospects of diagnosis, intravesical or systemic treatment, and novel drug delivery systems for BCa therapy are reviewed in this paper.

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Section: Proteinsmentioning

confidence: 99%

Section: Genomic Biomarkersmentioning

confidence: 99%

Advances in Diagnosis and Therapy for Bladder Cancer

2022

Cancers

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“…The test has lower sensitivity for low-grade tumors and missed about 25% of the high-grade recurrence. Nevertheless, XPERT test with two negative tests avoids nearly 75% of unnecessary cystoscopies [ 229 , 230 , 231 , 232 , 233 , 234 ]. ADXBLADDER™ test measures the expression of MCM5 transcript [ 235 , 236 , 237 ].…”

Section: Ease Of Developing Urine Biomarkersmentioning

confidence: 99%

Molecular Oncology of Bladder Cancer from Inception to Modern Perspective

Lokeshwar

López

Sarcan

et al. 2022

Cancers

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Within the last forty years, seminal contributions have been made in the areas of bladder cancer (BC) biology, driver genes, molecular profiling, biomarkers, and therapeutic targets for improving personalized patient care. This overview includes seminal discoveries and advances in the molecular oncology of BC. Starting with the concept of divergent molecular pathways for the development of low- and high-grade bladder tumors, field cancerization versus clonality of bladder tumors, cancer driver genes/mutations, genetic polymorphisms, and bacillus Calmette-Guérin (BCG) as an early form of immunotherapy are some of the conceptual contributions towards improving patient care. Although beginning with a promise of predicting prognosis and individualizing treatments, “-omic” approaches and molecular subtypes have revealed the importance of BC stem cells, lineage plasticity, and intra-tumor heterogeneity as the next frontiers for realizing individualized patient care. Along with urine as the optimal non-invasive liquid biopsy, BC is at the forefront of the biomarker field. If the goal is to reduce the number of cystoscopies but not to replace them for monitoring recurrence and asymptomatic microscopic hematuria, a BC marker may reach clinical acceptance. As advances in the molecular oncology of BC continue, the next twenty-five years should significantly advance personalized care for BC patients.

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“…Ten studies evaluated the test metrics of an RNAbased urine assay in patients under surveillance for NMIBC [20,[25][26][27][28][29][30][31][32][33]]. An overview of articles is shown in Table 3.…”

Section: Surveillance Setting Of Non-muscle Invasive Bladder Cancermentioning

confidence: 99%

“…An overview of articles is shown in Table 3. Eight studies assessed test performance of the Xpert Bladder Cancer Monitor (XBCM), evaluating 2257 patients in total [25,[27][28][29][30][31][32][33]. The XBCM test measures the same mRNA targets as the XBCD but uses a different algorithm and cut-off to make the tests suitable for the surveillance setting [18 & ,23].…”

Section: Surveillance Setting Of Non-muscle Invasive Bladder Cancermentioning

confidence: 99%

RNA-based urinary assays for non-muscle invasive bladder cancer

Pijpers

Jong

Zuiverloon

et al. 2022

Current Opinion in Urology

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Purpose of reviewTo provide an overview of the recent literature on RNA-based molecular urine assays for the diagnosis and surveillance of non-muscle invasive bladder cancer (NMIBC).Recent findingsArticles were eligible for inclusion if performance metrics sensitivity, specificity, and negative-predictive value (NPV) were reported or could be calculated. Only prospective studies published between 2020–2022 were included. Five out of fourteen studies addressed the primary diagnostic setting; the proportion of gross hematuria patients in all study populations was >50%. Only one study reported performance metrics within a microscopic hematuria subgroup. This study evaluated Xpert Bladder and reported a sensitivity: 73%, specificity: 84%, NPV: 99%, and PPV: 12%. Ten studies assessed test performance during surveillance for NMIBC. For the detection of high-grade (HG) and high-risk (HR) NMIBC, sensitivity, specificity, NPV, and PPV varied between 78–100%, 64–89%, 97.0–99.7%, and 9.2–39%.SummaryMultiple RNA-based urine assays have been investigated for the detection of urothelial cancer in the primary or surveillance setting. However, studies included within this review have important limitations, hampering the interpretation of study results. As such, performance metrics should be interpreted with caution and further research is required to evaluate the clinical impact of RNA-based urine assays in daily practice.

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The Role of New Technologies in the Diagnosis and Surveillance of Non-Muscle Invasive Bladder Carcinoma: A Prospective, Double-Blinded, Monocentric Study of the XPERT© Bladder Cancer Monitor and Narrow Band Imaging© Cystoscopy

Cited by 11 publications

References 37 publications

Advances in Diagnosis and Therapy for Bladder Cancer

Advances in Diagnosis and Therapy for Bladder Cancer

Molecular Oncology of Bladder Cancer from Inception to Modern Perspective

RNA-based urinary assays for non-muscle invasive bladder cancer

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