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

Recruiting now · Not applicable

Conditions studied: Bladder Cancer, Liquid Biopsy, Cystoscopy

In brief

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.

Key facts

Study ID

NCT07180212

Run by

Tianjin Medical University Second Hospital

People needed

360

Starts

2025-09-20

Expected to finish

2027-11-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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