Clinical Utility of Cxbladder Monitor for Patients with a History of Urothelial Carcinoma: A Physician–Patient Real-World Clinical Data Analysis

Lough, Tony; Luo, Qi; O’Sullivan, P.J.; Chemaslé, C.; Stotzer, Michael; Suttie, J. M.; Darling, David

doi:10.1007/s40487-018-0059-5

Cited by 8 publications

(7 citation statements)

References 21 publications

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“…The total number of requested invasive procedures was reduced from 425 to 379 (−11%) following disclosure of Cxbladder information. Another study obtained the same results—a reduction in the number of total and invasive procedures [ 106 ]. The CxBladder detect assay is FDA approved.…”

Section: Urine Dna/rna Based Assaysmentioning

confidence: 60%

Noninvasive Urine-Based Tests to Diagnose or Detect Recurrence of Bladder Cancer

Charpentier

Gutierrez

Guillaudeux

et al. 2021

Cancers

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Liquid biopsies are increasingly used for the diagnosis and follow-up of cancer patients. Urine is a body fluid that can be used to detect cancers and others diseases. It is noninvasive and easy to collect. To detect Bladder Cancer (BC), cytology is the first assay used. It is an effective way to detect high grade BC but has a high rate of equivocal results, especially for low grade BC. Furthermore, cystoscopy is used to confirm cytology results and to determine cancer status. Cystoscopy is also effective but highly invasive, and not well accepted by patients, especially for BC follow-up. In this review we survey the numerous assays recently developed in order to diagnose BC at an early stage, and to facilitate the follow-up of patients. We discuss their effectiveness, ease of use, and applications. Finally, we discuss assays that, in the future, could improve the diagnosis and management of BC patients.

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Section: Urine Dna/rna Based Assaysmentioning

confidence: 60%

Noninvasive Urine-Based Tests to Diagnose or Detect Recurrence of Bladder Cancer

Charpentier

Gutierrez

Guillaudeux

et al. 2021

Cancers

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“…Cxbladder® Monitor is commercially available that can be used to test recurrent urothelial carcinoma by detecting mRNA level of five urine mRNA biomarkers IGF, HOXA, MDK, CDC , and IL8R gene expression along with few clinical variables. The overall sensitivity of 91% and a negative predictive value of 96% within 95% CI was observed for this assay and had reduced sensitivity of 86% for low-grade Ta (54, 60).…”

Section: Urine Molecular Biomarkers For Precision Medicinementioning

confidence: 82%

Urine Biopsy—Liquid Gold for Molecular Detection and Surveillance of Bladder Cancer

2019

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With recent advancements in a non-invasive approach to cancer diagnosis and surveillance, the term “liquid biopsy” has gained traction but is currently limited by technological challenges in identifying and isolating circulating tumor cells (CTCs), proteins, cell-free DNA (cfDNA), or other nucleic acids. Tumor tissue biopsy, especially in genitourinary (GU) system is sometimes inadequate and requires invasive surgical options, especially for upper tract urothelial cancer. Urine can prove to be “liquid gold” since it may be a more abundant source of tumor-derived material without the background noise; however, urine DNA (uDNA) may be associated with low mutant allele fraction (MAF). Molecular detection of mutations in uDNA requires a sensitive and accurate method of analysis that allows a high depth of sequencing while minimizing artifacts. Several sequencing approaches to address this hurdle using enhanced library preparation techniques such as Tagged amplicon deep sequencing (TAm-Seq), Safe-SeqS, FAST-SeqS, and CAPP-Seq approaches have been developed. Urine biopsy utilizing next-generation sequencing (NGS) can prove useful at all stages of urologic malignancy care, where urine can be collected to aid in clinical decision making through the identification of commonly known mutations, and potentially reduce or avoid all forms of invasive procedures.

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“…They found that 77.8% of patients were safely managed by only one cystoscopy every 2 years, reducing the total number of annual cystoscopies by 39%. This was reflected in a real world data analysis identifying this advantage of CxBM in clinical practice to have driven its increased utility ( 76 ).…”

Section: Gene-related Biomarkersmentioning

confidence: 99%

Biomarkers in Bladder Cancer Surveillance

Sugeeta

Sharma

et al. 2021

Front. Surg.

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Aim: This is a narrative review with an aim to summarise and describe urinary biomarkers in the surveillance of non-muscle-invasive bladder cancer (NMIBC). It provides a summary of FDA-approved protein biomarkers along with emerging ones which utilise genetic, epigenetic and exosomal markers. We discuss the current limitations of the available assays.Background: Current guidelines advice a combination of cystoscopy, imaging,and urine cytology in diagnosis and surveillance. Although cytology has a high specificity, it is limited by low sensitivity particularly in low grade tumours. There are six FDA-approved urinary assays for diagnosis and surveillance of bladder cancer. They have shown to improve sensitivity and specificity to be used alongside cytology and cystoscopy but have a lower specificity in comparison to cytology and false positives often occur in benign conditions. Recent developments in laboratory techniques has allowed for use of markers which are RNA-, DNA-based as well as extracellular vesicles in the past decade.Methods: Using the PubMed/Medline search engines as well as Google Scholar, we performed an online search using the terms “bladder cancer,” “non-muscle invasive bladder cancer,” and “urine biomarkers” with filter for articles in English published up to May 2021. Systematic reviews and original data of clinical trials or observational studies which contributed to the development of the biomarkers were collated.Results: Biomarkers identified were divided into FDA-approved molecular biomarkers, protein biomarkers and gene-related biomarker with a table summarising the findings of each marker with the most relevant studies. The studies conducted were mainly retrospective. Due to the early stages of development, only a few prospective studies have been done for more recently developed biomarkers and limited meta-analyses are available.Therefore a detailed evaluation of these markers are still required to decide on their clinical use.Conclusion: Advancements of analytical methods in BC has driven the research towards non-invasive liquid-based biomarkers in adjunct to urine cytology. Further large prospective studies are required to determine its feasibility in a clinical setting as they are not effective when used in isolation as they have their limitation. With the ongoing pandemic, other than reduction in costs and increased accuracy, the need for biomarkers to cope with delay in cystoscopies in diagnosis and surveillance is crucial. Thus clinical trials with direct comparison is required to improve patient care.

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Clinical Utility of Cxbladder Monitor for Patients with a History of Urothelial Carcinoma: A Physician–Patient Real-World Clinical Data Analysis

Cited by 8 publications

References 21 publications

Noninvasive Urine-Based Tests to Diagnose or Detect Recurrence of Bladder Cancer

Noninvasive Urine-Based Tests to Diagnose or Detect Recurrence of Bladder Cancer

Urine Biopsy—Liquid Gold for Molecular Detection and Surveillance of Bladder Cancer

Biomarkers in Bladder Cancer Surveillance

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