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Diagnostics
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Diagnostic and Prognostic Non-Invasive Markers in Bladder Cancer
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Diagnostic and Prognostic Non-Invasive Markers in Bladder Cancer

A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Clinical Diagnosis and Prognosis".

Deadline for manuscript submissions: 31 October 2026 | Viewed by 3519

Special Issue Editors

Prof. Dr. Qiang Lv

E-Mail Website
Guest Editor
Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210036, China
Interests: bladder cancer; prostate cancer; kidney cancer; renal pelvis cancer; adrenal gland tumors
Special Issues, Collections and Topics in MDPI journals
Dr. Xiao Yang

E-Mail Website
Guest Editor
Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210036, China
Interests: bladder cancer; urology
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Bladder cancer (Bca) remains one of the most prevalent malignancies of the urinary tract, characterized by high incidence, frequent recurrence, and rapid disease progression. Notably, the therapeutic strategies for muscle-invasive (MIBC) and non-muscle-invasive bladder cancer (NMIBC) differ significantly, underscoring the urgent need for reliable diagnostic and prognostic markers.

Recent advances in analytical technologies—radiological examination (MRI or CT) and liquid biopsy platforms—have enabled the discovery of novel non-invasive markers for early detection, disease stratification, and treatment response monitoring. Compared to traditional pathological biomarkers, these emerging approaches offer non-invasive, real-time, and reproducible alternatives based on imaging parameters, urinary sediments, and plasma analyses. Furthermore, the integration of artificial intelligence and bioinformatics holds promise for accelerating the screening and validation of potential targets.

This Special Issue invites original research and review articles addressing the development, validation, and clinical translation of BCa’s diagnostic and prognostic markers. We welcome contributions spanning molecular mechanisms, technological innovations, and clinical implementation studies aimed at improving patient outcomes and alleviating the global burden of bladder cancer.

We look forward to receiving your contributions.

Prof. Dr. Qiang Lv
Dr. Xiao Yang
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Diagnostics is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • bladder cancer
  • diagnostic and prognostic markers
  • non-invasive
  • artificial intelligence

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Published Papers (4 papers)

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19 pages, 1768 KB  
Article
Prognostic Impact of the Gustave Roussy Immune Score on Cancer-Specific Survival and Treatment Completion in Patients with Bladder Cancer
by Neslihan Özyurt and Aykut Turhan
Diagnostics 2026, 16(4), 574; https://doi.org/10.3390/diagnostics16040574 - 14 Feb 2026
Viewed by 581
Abstract
Background: Bladder cancer has diverse clinical outcomes, even in patients receiving curative treatment. Traditional clinicopathological indicators inadequately assess individual risk. The Gustave Roussy Immune Score (GRIm-score), which combines albumin, lactate dehydrogenase (LDH), and neutrophil-to-lymphocyte ratio (NLR), is a prognostic factor for solid [...] Read more.
Background: Bladder cancer has diverse clinical outcomes, even in patients receiving curative treatment. Traditional clinicopathological indicators inadequately assess individual risk. The Gustave Roussy Immune Score (GRIm-score), which combines albumin, lactate dehydrogenase (LDH), and neutrophil-to-lymphocyte ratio (NLR), is a prognostic factor for solid tumors; however, its role in bladder cancer remains unclear. Methods: In this retrospective cohort study, patients with bladder cancer confirmed through histopathology received bladder-preserving multimodal therapy or radical cystectomy between October 2010 and April 2025. Participants were grouped into low (0–1) and high (2–3) GRImS categories for analysis. The study examined cancer-specific survival (CSS) and the secondary outcomes of progression-free survival (PFS), overall survival (OS), and treatment completion. Survival analyses were performed using the Kaplan–Meier method and Cox proportional hazard regression. Results: A total of 89 patients participated in the study, with 73 (82.0%) and 16 (18.0%) having low and high GRIm-Score. During a median follow-up of 21.5 months, patients with a high GRIm-score had significantly shorter PFS, OS, and CSS than those with a low GRIm-score. The median CSS was 14.07 months for the high GRIm-score group and 27.75 months for the low GRIm-score group (p = 0.004). In multivariable Cox regression analysis, a high GRIm-score was independently associated with an increased cancer-specific mortality risk (hazard ratio [HR] 2.48, 95% confidence interval [CI], 1.31–4.67; p = 0.005). Treatment completion was lower in the high GRIm-score group (31.3% vs. 64.4%, p = 0.031). Conclusions: The GRIm-score serves as an independent prognostic indicator for cancer-specific survival in patients with bladder cancer undergoing curative treatment and is related to therapy completion. Full article
(This article belongs to the Special Issue Diagnostic and Prognostic Non-Invasive Markers in Bladder Cancer)
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15 pages, 4732 KB  
Article
The Diagnostic Performance of a Four-Gene Digital Droplet PCR Panel for Urine Liquid Biopsy in Urothelial Bladder Cancer
by Mark Jain, Alexander Tivtikyan, Dmitry Kislyakov, Tagir Rakhmatullin, David Kamalov, Vladislav Kokarev, Lolita Vorobeva, Larisa Samokhodskaya, Maria Zvereva and Armais Kamalov
Diagnostics 2026, 16(1), 69; https://doi.org/10.3390/diagnostics16010069 - 24 Dec 2025
Viewed by 913
Abstract
Background: Urothelial bladder carcinoma (UBC) is a disease that lacks robust non-invasive laboratory biomarkers. Recently, urine liquid biopsy has emerged as a promising tool for diagnosis and surveillance of patients with these tumors. The aim of this study was to evaluate the [...] Read more.
Background: Urothelial bladder carcinoma (UBC) is a disease that lacks robust non-invasive laboratory biomarkers. Recently, urine liquid biopsy has emerged as a promising tool for diagnosis and surveillance of patients with these tumors. The aim of this study was to evaluate the diagnostic potential of a urinary tumor DNA detection panel, which included eight common point mutations in TERT, GPR126, FGFR3, and PIK3CA genes, in UBC. Methods: The study included patients with histologically confirmed UBC (n = 88) and patients with cystitis, bladder leiomyomas, or other non-malignant conditions (control group; n = 72). DNA was extracted from whole urine specimens. ddPCR analysis was performed using the Bio-Rad QX200 AutoDG ddPCR system. Results: Urinary tumor DNA detection panel demonstrated a sensitivity of 78.4% and a specificity of 100% (AUC−ROC = 0.892). Detection rates for the analyzed mutations were the following: 54.5%, 37.5%, 28.4%, and 38.6% for TERT, GPR126, FGFR3, and PIK3CA, respectively. Pairwise comparisons of mutant allele fractions (MAFs) for samples simultaneously positive for ≥2 mutations revealed an absence of significant differences (p > 0.05), except for the pair of FGFR3 vs. PIK3CA (p = 0.03). MAFs were not associated with any clinical and demographic features (p > 0.05), with the only exception being the tumor size: patients with tumors larger than 2.16 cm3 had higher MAFs than the rest (23.4 [1.8; 46.3] vs. 1.6 [0; 24.6] %, respectively, p = 0.02). Conclusions: Upon further validation, the presented tumor DNA detection panel for ddPCR might become a useful tool for diagnostic purposes in UBC. Full article
(This article belongs to the Special Issue Diagnostic and Prognostic Non-Invasive Markers in Bladder Cancer)
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18 pages, 9853 KB  
Article
Overexpression of CDC20 Confer a Poorer Prognosis in Bladder Cancer Identified by Gene Co-Expression Network Analysis
by Xuejian Yang, Yunjie Guo, Lanyu Wang, Zengli Miao, Xiaojie Lu, Jun Ruan and Wei Tian
Diagnostics 2025, 15(23), 3016; https://doi.org/10.3390/diagnostics15233016 - 27 Nov 2025
Viewed by 755
Abstract
Background/Objectives: Bladder cancer (BCa) ranks as the tenth most prevalent malignancy worldwide, characterized by high morbidity and mortality rates. Despite advancements in understanding its pathogenesis, the identification of robust prognostic biomarkers remains critical for improving clinical outcomes. This study aims to identify [...] Read more.
Background/Objectives: Bladder cancer (BCa) ranks as the tenth most prevalent malignancy worldwide, characterized by high morbidity and mortality rates. Despite advancements in understanding its pathogenesis, the identification of robust prognostic biomarkers remains critical for improving clinical outcomes. This study aims to identify and validate novel prognostic markers for BCa through integrated bioinformatics and experimental approaches. Methods: Gene expression data and clinical information were obtained from the GEO (GSE13507) and TCGA databases. Differential gene expression analysis and weighted gene co-expression network analysis (WGCNA) were employed to identify overlapping genes. Functional enrichment analysis was performed to explore biological functions, followed by protein–protein interaction (PPI) network construction and survival analysis. Key candidate genes were screened using the CytoHubba plugin in Cytoscape. CDC20 expression was validated through RT-qPCR, and its functional role in BCa cells was assessed in vitro. Results: Eight candidate hub genes (TROAP, TPX2, TOP2A, KIF2C, AURKA, CDC20, PRC1, and AURKB) were identified. Survival analysis revealed that high CDC20 expression was significantly associated with decreased overall survival in BCa patients. Mechanistic investigations demonstrated that CDC20 promotes tumor invasion and growth by modulating mitosis and cell cycle progression, while also influencing the tumor microenvironment through immune cell regulation. Experimental validation confirmed the tumor-promoting role of CDC20 in BCa cells. Conclusions: This study identifies CDC20 as a key prognostic biomarker for bladder cancer, providing novel insights for early diagnosis, clinical treatment, and prognosis assessment. The findings highlight the potential of CDC20 as a therapeutic target and underscore the value of integrated bioinformatics and experimental validation in biomarker discovery. Full article
(This article belongs to the Special Issue Diagnostic and Prognostic Non-Invasive Markers in Bladder Cancer)
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16 pages, 1220 KB  
Systematic Review
Diagnostic Performance and Clinical Utility of the Uromonitor® Molecular Urine Assay for Urothelial Carcinoma of the Bladder: A Systematic Review and Diagnostic Accuracy Meta-Analysis
by Julio Ruben Rodas Garzaro, Anton Kravchuk, Maximilian Burger, Ingmar Wolff, Steffen Lebentrau, José Rubio-Briones, João Paulo Brás, Christian Gilfrich, Stephan Siepmann, Sascha Pahernik, Axel S. Merseburger, Axel Heidenreich and Matthias May
Diagnostics 2026, 16(2), 285; https://doi.org/10.3390/diagnostics16020285 - 16 Jan 2026
Viewed by 772
Abstract
Background: Urine cytology remains widely used for surveillance of non-muscle-invasive bladder cancer despite well-known limitations in sensitivity, especially for low-grade tumors. Uromonitor®, a molecular assay detecting TERT promoter, FGFR3, and KRAS mutations in voided urine, has emerged as a promising [...] Read more.
Background: Urine cytology remains widely used for surveillance of non-muscle-invasive bladder cancer despite well-known limitations in sensitivity, especially for low-grade tumors. Uromonitor®, a molecular assay detecting TERT promoter, FGFR3, and KRAS mutations in voided urine, has emerged as a promising adjunct. To evaluate its suitability for routine use, a consolidated assessment of diagnostic performance and a direct comparison with urine cytology are needed. Methods: We conducted a prospectively registered systematic review (PROSPERO CRD420251173244), synthesizing all available studies that evaluated Uromonitor® for the detection of urothelial carcinoma of the bladder (UCB). Methodological quality was assessed using the QUADAS-2 framework, and certainty of evidence was evaluated following GRADE for diagnostic tests. Sensitivity was prespecified as the primary endpoint. Comparative datasets were identified, and random-effects meta-analyses were performed for sensitivity, specificity, accuracy, and predictive values (PVs). Results: Across eight cohorts evaluating Uromonitor®, 832 of 3196 patients (26.0%) had histologically confirmed UCB. Aggregated sensitivity was 0.55 (95% CI 0.52–0.58). Specificity was 0.95 (0.94–0.96). Accuracy was 0.85 (0.83–0.86). PPV was 0.79 (0.76–0.82), and NPV was 0.86 (0.84–0.87). Across seven paired datasets, urine cytology demonstrated a sensitivity of 0.42, a specificity of 0.91, an accuracy of 0.78, a PPV of 0.64, and an NPV of 0.81. Pooled odds ratio for sensitivity was 3.16 (0.73–13.76), while diagnostic accuracy yielded 1.71 (1.01–2.90). Differences in specificity and NPV were not statistically significant, whereas the PPV favored Uromonitor®, reaching statistical significance in pooled analyses. Conclusions: Uromonitor® demonstrates higher sensitivity and improved accuracy compared with urine cytology, although current performance remains insufficient for stand-alone surveillance. The sensitivity estimate showed very low certainty due to pronounced heterogeneity, underscoring the need for careful interpretation. With advancing DNA recovery methods, incorporation of droplet digital PCR, and rigorous evaluations in prospective multicenter studies, Uromonitor® may become an integral element of risk-adapted follow-up strategies. Full article
(This article belongs to the Special Issue Diagnostic and Prognostic Non-Invasive Markers in Bladder Cancer)
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