NCT07180212Active, not recruiting
Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer
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)
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- 20 Sept 2025
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Tianjin Medical University Second Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07180212
What you commit to
- Study type: Interventional
- Planned participants: 360
- From 20 Sept 2025 to the primary completion date, 1 Oct 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Haerbin | China | Unknown status |
| The Second Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Nanchang Second People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Tianjin Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The Second Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| General Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Xingtai People's Hospital Coordinator of this site? Confirm its status | Xingtai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.