Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer

Official title

The Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multicenter Clinical Study (Truce-LB02)

Overview

Non-muscle-invasive bladder cancer (NMIBC) is usually treated with surgery to remove the tumor (transurethral resection of bladder tumor, or TURBT), often followed by bladder-instilled medications to reduce the chance of the cancer coming back. Even with this treatment, high-grade NMIBC can return or progress, so patients need regular check-ups, usually with cystoscopy (a camera examination of the bladder) and urine cytology. Cystoscopy is effective but invasive, can cause discomfort, and carries risks such as infection and bleeding. This makes follow-up costly and sometimes burdensome for patients. This study is testing whether a urine tumor DNA (utDNA) test - a type of "liquid biopsy" that detects cancer-related DNA changes in urine - can help guide the timing of cystoscopy for people with high-risk or very high-risk NMIBC. utDNA testing is non-invasive and has shown high accuracy in detecting bladder cancer, sometimes spotting signs of recurrence earlier than standard methods. By combining utDNA testing with cystoscopy, we hope to safely reduce the number of unnecessary cystoscopies without missing cancer recurrences. The study will evaluate whether this approach can make bladder cancer follow-up more comfortable, more precise, and more efficient.

Interventions

• Diagnostic test utDNA testing + Urine Cytology
  Participants undergo urine tumor DNA (utDNA) testing and urine cytology every 3 months, and cystoscopy once per year. If either utDNA or urine cytology is positive, an additional cystoscopy will be performed. If urine cytology is positive but cystoscopy is negative, or if two consecutive utDNA tests are positive while cystoscopy remains negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.
• Diagnostic test Cystoscopy + Urine Cytology
  Participants undergo cystoscopy and urine cytology every 3 months as per standard high-risk NMIBC surveillance. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.

Primary outcome measures

• Recurrence-Free Survival (RFS) [Time frame: Up to 24 months from randomization.]
• Mean Number of Cystoscopic Examinations per Patient Within 2 Years [Time frame: Up to 24 months from randomization.]

Secondary outcome measures (7)

• Progression-Free Survival (PFS) [Time frame: Up to 24 months from randomization.]
• Sensitivity of serial utDNA testing for detection of intravesical recurrence [Time frame: From randomization to 24 months.]
• Specificity of serial utDNA testing for detection of intravesical recurrence [Time frame: From randomization to 24 months.]
• Positive Predictive Value (PPV) of serial utDNA testing for detection of intravesical recurrence [Time frame: From randomization to 24 months.]
• Negative Predictive Value (NPV) of serial utDNA testing for detection of intravesical recurrence [Time frame: From randomization to 24 months.]
• Patient-reported health-related quality of life measured by EQ-5D-5L [Time frame: Up to 24 months from randomization.]
• Patient-reported health-related quality of life measured by EORTC QLQ-C30 [Time frame: Up to 24 months from randomization]

Eligibility criteria

Inclusion criteria

• Male or female participants aged 18 years or older.
• Histologically confirmed high-risk or very high-risk non-muscle-invasive urothelial carcinoma (NMIBC) of the bladder, as defined by the EAU 2025 NMIBC guidelines, or bladder tumors in which high-risk/very high-risk NMIBC constitutes more than 50% of the pathological composition, diagnosed within the past 2 years, with no evidence of muscle-invasive bladder cancer or metastatic disease.
• Prior to enrollment, participants must have undergone either:

A.Second transurethral resection of bladder tumor (re-TURBT), or B.Complete initial TURBT with negative basal margins, peripheral margins, and multiple site biopsies, with pathological specimens including detrusor muscle and showing no residual tumor, and negative urine cytology at 2 weeks post-surgery.

Exclusion criteria

1.History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years or concurrent diagnosis of upper urinary tract urothelial carcinoma.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 8 centers

• Xingtai People's Hospital — Xingtai
• Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University — Guangzhou
• The First Affiliated Hospital of Harbin Medical University — Haerbin
• The Second Affiliated Hospital of Kunming Medical University — Kunming
• Nanchang Second People's Hospital — Nanchang
• The second hospital of Tianjin Medical University — Tianjin
• General Hospital of Tianjin Medical University — Tianjin
• Tianjin Hospital — Tianjin

Identifiers

NCT: NCT07180212 · Truce-LB02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗