Bladder Cancer - Potential of Urinary Mutation and Methylation Biomarkers in Selecting Candidates for Repeat Transurethral Resection of Bladder Tumor in Non–muscle-invasive Bladder Cancer: A Prospective Multicenter Study

Sep 23, 2026

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Repeat transurethral resection of bladder tumor (re-TURBT) for non–muscle-invasive bladder cancer (NMIBC) remains debated, and whether liquid biopsy can predict residual tumor status and spare selected patients is unclear. This prospective multicenter study evaluated the urinary OncoUrine assay for mutation and methylation markers for determining the need for re-TURBT in NMIBC candidates. Among 151 patients, OncoUrine showed sensitivity 77%, specificity 78%, PPV 62%, and NPV 88% for residual tumor, with higher accuracy in intermediate- and selected high-risk subgroups. OncoUrine positivity was the sole independent predictor of recurrence risk, and enables avoidance of unnecessary re-TURBT.

LanguageEnglish

CategoryHealthcare

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Abstract

Background and objective

Methods

Key findings and limitations

Introduction

EUROPEAN U ROLOGY OPEN SCIE N C E 7 7 ( 202 5 ) 4 9 – 57 available [at www.sciencedirect.com](at www.sciencedirect.com) journal [homepage: www.eu-openscience.europeanurology. com](homepage: www.eu-openscience.europeanurology. com) | Bladder Cancer
Potential of Urinary Mutation and Methylation Biomarkers in Selecting Candidates for Repeat Transurethral Resection of Bladder Tumor in Non–muscle-invasive Bladder Cancer: A Prospective Multicenter Study
Xiao Yanga,, Lingkai Cai a,b,, Yaqun Xinc,, Xinfeng Chend, Bing Zheng d, Jie Han e, Lin Yuan e, Xuejian Yangf, Pengchao Lia,f, Juntao Zhuang a, Peikun Liu a, Ruixi Yu a, Rongjie Baia, Yiyang Liu a, Tonghui Mag,*, Qiang Cao a,*, Qiang Lua, *
a Department of Urology, First Afﬁliated Hospital of Nanjing Medical University, Nanjing, China; b Department of Urology, Wuxi Medical Center of Nanjing Medical University, Wuxi, China; c Hangzhou Jichenjunchuang Medical Laboratory, Hangzhou, China; d Department of Urology, Nantong First People’s Hospital, Nantong, China; e Department of Urology, Jiangsu Province Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China; f Department of Urology, Suqian First Hospital, Suqian, China; g Genecn-Biotech, Hangzhou, China | | | --- | --- | | Article info | Abstract
Background and objective: The necessity of repeat transurethral resection of bladder tumor (re-TURBT) in patients with non–muscle-invasive bladder cancer (NMIBC) remains a matter of debate. The role of liquid biopsy in predicting residual tumor status and selecting patients who can be spared re-TURBT is still undeﬁned. The aim of our study was to assess the efﬁcacy of the urinary OncoUrine assay for mutation and methylation markers in determining the necessity for re-TURBT in NMIBC.
Methods: We prospectively recruited patients with NMIBC who were candidates for re-TURBT. Urine samples for OncoUrine testing and exfoliated cytology analysis were collected after initial TURBT, followed by re-TURBT.
Key findings and limitations: Among 151 patients with NMIBC, 48 (32%) had residual tumor at re-TURBT, and 87 (58%) had detrusor muscle (DM) in their initial TURBT specimen. The OncoUrine test showed sensitivity of 77%, speciﬁcity of 78%, positive predictive value of 62%, and negative predictive value (NPV) of 88% for residual tumor, while exfoliated cytology showed corresponding values of 20%, 96%, 69%, and 72%. Stratiﬁed analyses revealed higher OncoUrine accuracy in predicting disease-free status in intermediate-risk NMIBC (NPV 98%) and in high-risk NMIBC cases with DM in the initial TURBT specimen (NPV 92%). At 18-mo follow-up for 131 patients, 20 had experienced tumor recurrence, for which
These authors contributed equally to this work.
*
Corresponding authors. Department of Urology, First Afﬁliated Hospital of Nanjing Medical University, Nanjing 210029, China (Q. Lu, Q. Cao). Genecn-Biotech, Hangzhou 310000, China (T. Ma). E-mail [addresses:](addresses: math11@mails.jlu.edu.cn)[ math11@mails.jlu.edu.cn](addresses: math11@mails.jlu.edu.cn) (T. Ma), [qiang_cao@126.com](qiang_cao@126.com) (Q. Cao), doctorlvqiang@nj
[mu.edu.cn](mu.edu.cn) (Q. Lu). | | Article history:
Accepted May 24, 2025
Associate Editor:
M. Carmen Mir | | | Keywords:
Urine liquid biopsy
Mutation
Methylation
Non–muscle-invasive bladder cancer
Repeat transurethral resection of bladder tumor
Residual tumor
Recurrence | | | | | [https://doi.org/10.1016/j.euros.2025.05.011](https://doi.org/10.1016/j.euros.2025.05.011) 2666-1683/􀀁 2025 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY-NC-ND license ([http://creativecommons.org/licenses/by-nc-nd/4.0/](http://creativecommons.org/licenses/by-nc-nd/4.0/)). OncoUrine positivity was the only independent factor predictive for the risk of recurrence (hazard ratio 3.67, 95% conﬁdence interval 1.49–9.00; p = 0

FAQs

Why is repeat TURBT needed in non–muscle-invasive bladder cancer?

Repeat TURBT helps address understaging and residual disease risk, and guidelines recommend it for selected NMIBC patients within 2–6 weeks after initial TURBT. However, its universal benefit is questioned because many patients have no residual tumor.

How was the urinary OncoUrine assay used in the study?

NMIBC patients eligible for re-TURBT provided urine samples after initial TURBT for OncoUrine testing and exfoliated cytology. These were followed by re-TURBT to confirm residual tumor status and assess recurrence.

What were the main performance results of OncoUrine versus exfoliated cytology?

For residual tumor, OncoUrine achieved sensitivity 77% and specificity 78% with NPV 88%, while exfoliated cytology showed lower sensitivity (20%) but higher specificity (96%) and NPV 72%. Stratified analyses indicated improved OncoUrine accuracy in certain intermediate- and high-risk groups.

Sep 23, 2026

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