Research progress and clinical translation prospects of multiple urinary biomarkers in non-invasive diagnosis of urothelial carcinoma
- 1Department of Urology, The First Hospital of Jilin University
Abstract
Urothelial carcinoma is a common urinary malignancy with high incidence, recurrence, and mortality. Early diagnosis is pivotal for improving patient outcomes. Current standards have important limitations: cystoscopy, although the cornerstone of diagnosis and surveillance, is invasive and costly, while cytology has limited sensitivity for low-grade or early-stage lesions. Urine, as a liquid biopsy, offers a non-invasive and repeatable approach for sampling urogenital pathology, with the potential for longitudinal monitoring through serial collection. The review covers urinary multi-omics biomarkers, including cfDNA/methylation, miRNAs, extracellular vesicles (EVs), and proteomic/metabolomic signatures. We summarize their performance in early detection, staging, and postoperative monitoring. Integrated multi-analyte models, including true multi-omics assays and multiplex single-omics panels, generally outperform single biomarkers, with some panels achieving >90% sensitivity and >95% specificity in prospective cohorts. Despite progress, several challenges remain: standardization, large-scale prospective validation, and regulatory/reimbursement barriers. We conclude that urinary multi-omics diagnostics are promising complementary tools that may optimize surveillance and risk stratification. Still, limited prospective validation, lack of standardization, and the persistent risk of false-negative results constrain adoption. On current evidence, they are not positioned to replace cystoscopy, which remains the cornerstone of diagnosis and surveillance, particularly in non-muscle-invasive bladder cancer (NMIBC). However, their most realistic and immediate clinical role is as a triage tool to optimize the selective use of cystoscopy—particularly for risk-stratifying patients with hematuria, adjudicating equivocal cytology, and potentially reducing the frequency of invasive surveillance in low-risk NMIBC patients.
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BibTeX
@article{li2026research,
title = {{Research progress and clinical translation prospects of multiple urinary biomarkers in non-invasive diagnosis of urothelial carcinoma}},
author = {Shuxin Li and Lei Wang and Baoshan Gao},
journal = {Frontiers in Oncology},
year = {2026},
month = oct,
doi = {10.3389/fonc.2026.1984066},
url = {https://www.frontiersin.org/articles/10.3389/fonc.2026.1984066/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Research progress and clinical translation prospects of multiple urinary biomarkers in non-invasive diagnosis of urothelial carcinoma
AU - Shuxin Li
AU - Lei Wang
AU - Baoshan Gao
PY - 2026
DA - 2026/10/08
JO - Frontiers in Oncology
DO - 10.3389/fonc.2026.1984066
UR - https://www.frontiersin.org/articles/10.3389/fonc.2026.1984066/full
AB - Urothelial carcinoma is a common urinary malignancy with high incidence, recurrence, and mortality. Early diagnosis is pivotal for improving patient outcomes. Current standards have important limitations: cystoscopy, although the cornerstone of diagnosis and surveillance, is invasive and costly, while cytology has limited sensitivity for low-grade or early-stage lesions. Urine, as a liquid biopsy, offers a non-invasive and repeatable approach for sampling urogenital pathology, with the potential for longitudinal monitoring through serial collection. The review covers urinary multi-omics biomarkers, including cfDNA/methylation, miRNAs, extracellular vesicles (EVs), and proteomic/metabolomic signatures. We summarize their performance in early detection, staging, and postoperative monitoring. Integrated multi-analyte models, including true multi-omics assays and multiplex single-omics panels, generally outperform single biomarkers, with some panels achieving >90% sensitivity and >95% specificity in prospective cohorts. Despite progress, several challenges remain: standardization, large-scale prospective validation, and regulatory/reimbursement barriers. We conclude that urinary multi-omics diagnostics are promising complementary tools that may optimize surveillance and risk stratification. Still, limited prospective validation, lack of standardization, and the persistent risk of false-negative results constrain adoption. On current evidence, they are not positioned to replace cystoscopy, which remains the cornerstone of diagnosis and surveillance, particularly in non-muscle-invasive bladder cancer (NMIBC). However, their most realistic and immediate clinical role is as a triage tool to optimize the selective use of cystoscopy—particularly for risk-stratifying patients with hematuria, adjudicating equivocal cytology, and potentially reducing the frequency of invasive surveillance in low-risk NMIBC patients.
SN - 2234-943X
ER -