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

Tianjin Medical University Second Hospital

Status: Enrolling

Conditions: Bladder Cancer; Cystoscopy; Liquid Biopsy

Treatments: Diagnostic Test: utDNA testing + Urine Cytology; Diagnostic Test: Cystoscopy + Urine Cytology

Study type: Interventional

Funder types: Other

Identifiers

NCT07180212

Truce-LB02

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female participants aged 18 years or older.
2. 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.
3. 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

Arm A

Experimental group

Description:

Participants will 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.

Treatment:

Diagnostic Test: utDNA testing + Urine Cytology

Arm B

Active Comparator group

Description:

Participants will undergo cystoscopy and urine cytology every 3 months. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.

Treatment:

Diagnostic Test: Cystoscopy + Urine Cytology