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Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer

RecruitingNAAges 18 Years - anyAllTianjin Medical University Second Hospital
NCT07187635 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery to remove residual tumor, confirm staging, and obtain additional pathological information. However, the benefits of routine re-TURBT for all high-risk patients remain controversial, as many patients may not have residual disease, while the procedure carries surgical and anesthetic risks, physical and psychological burden, and additional healthcare costs. Urine tumor DNA (utDNA) refers to DNA fragments shed by tumor cells into urine. It can be detected using molecular assays with high sensitivity and specificity, offering a non-invasive method

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📋 Eligibility rules (as published)
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for the study: 1. Male or female, aged 18 years or older. 2. Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease. 3. Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (\>50%). 4. At least one of the following conditions: 1. Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection. 2. Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ \[CIS\]). 3. T1 stage tumor. 5. Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT. 6. Willingness to provide tumor tissue samples for pathological examination. 7. Willingness to undergo genetic testing required for the trial. Exclusion Criteria: 1. Contraindications to transurethral resection of bladder tumor (TURBT). 2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).
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What it tests

  • Second Transurethral Resection of Bladder Tumor (re-TURBT)
  • utDNA Testing (Urine Tumor DNA Detection)
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Where

7 sites
Nanchang Second People's Hospital
Nanchang, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, China
Xingtai People's Hospital
Xingtai, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
Renji Hospital
Shanghai, China
The Second Hospital of Tianjin Medical University
Tianjin, China
General Hospital of Tianjin Medical University
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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