Guiding cystoscopy timing with urine tumor DNA testing for 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)
This project will try to see if checking tumor DNA in urine can help decide when people with high-risk non‑muscle‑invasive bladder cancer need cystoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University Second Hospital Academic / other |
| Locations | 8 sites (Xingtai, Hebei and 7 other locations) |
| Trial ID | NCT07180212 on ClinicalTrials.gov |
What this trial studies
The trial will enroll adults with high‑risk or very high‑risk non‑muscle‑invasive bladder cancer who have had a complete TURBT or a re‑TURBT and recent negative urine cytology. Participants will provide urine samples for tumor DNA (utDNA) testing alongside standard urine cytology during scheduled follow-up visits. Cystoscopy timing will be informed by utDNA and cytology results rather than only by routine schedule, with clinicians performing cystoscopy when urine tests suggest recurrence or per standard care. Outcomes will include detection of recurrence, timing and number of cystoscopies, and safety measures to determine whether utDNA can safely reduce invasive procedures.
Who should consider this trial
Good fit: Adults (18+) with histologically confirmed high‑risk or very high‑risk NMIBC diagnosed within the past two years who had a complete TURBT or re‑TURBT and negative urine cytology at two weeks are ideal candidates.
Not a fit: Patients with muscle‑invasive or metastatic disease, recent or concurrent upper urinary tract cancers, or incomplete initial resections are unlikely to benefit from this utDNA‑guided approach.
Why it matters
Potential benefit: If successful, this approach could reduce the number of invasive, uncomfortable cystoscopies and potentially detect recurrences earlier using a simple urine test.
How similar studies have performed: Prior research on urinary tumor DNA has shown high accuracy and in some cases earlier detection of bladder cancer recurrence, but using utDNA specifically to guide cystoscopy timing remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xingtai, Hebei and 7 other locations
- Xingtai People's Hospital — Xingtai, Hebei, China (Recruiting)
- Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University — Guangzhou, China (Recruiting)
- The First Affiliated Hospital of Harbin Medical University — Haerbin, China (Recruiting)
- The Second Affiliated Hospital of Kunming Medical University — Kunming, China (Recruiting)
- Nanchang Second People's Hospital — Nanchang, China (Recruiting)
- The second hospital of Tianjin Medical University — Tianjin, China (Recruiting)
- General Hospital of Tianjin Medical University — Tianjin, China (Recruiting)
- Tianjin Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Hailong Hu, MD
- Email: huhailong@tmu.edu.cn
- Phone: +8613662096232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.