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 for bladder cancer diagnosis and surveillance. Previous studies have shown that positive utDNA results after initial TURBT may be associated with residual disease and higher recurrence risk. This multicenter, randomized controlled trial aims to evaluate whether utDNA testing can accurately identify NMIBC patients who are most likely to benefit from re-TURBT, thereby guiding the decision to perform the procedure. The goal is to optimize patient selection for re-TURBT, reduce unnecessary surgeries, and improve patient quality of life while maintaining oncologic safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Participants with NMIBC who have undergone initial TURBT will not receive utDNA testing and will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery, in accordance with current clinical guidelines.
Participants with NMIBC who have undergone initial TURBT will receive urine tumor DNA (utDNA) testing. If utDNA is positive, the patient will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery. If utDNA is negative, re-TURBT will be omitted and patients will proceed to guideline-based adjuvant therapy or surveillance.
Nanchang Second People's Hospital
Nanchang, Anhui, China
RECRUITINGSun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGXingtai People's Hospital
Xingtai, Hebei, China
RECRUITINGThe Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
RECRUITINGRenji Hospital
Shanghai, China
RECRUITINGThe Second Hospital of Tianjin Medical University
Tianjin, China
RECRUITINGGeneral Hospital of Tianjin Medical University
Tianjin, China
RECRUITINGRecurrence-free survival (RFS)
Time from randomization to the first documented event of bladder tumor recurrence (any grade), upper tract urothelial recurrence.
Time frame: Up to 24 months from randomization
Progression-free survival (PFS)
Time from initial TURBT to disease progression (development of muscle-invasive bladder cancer, distant metastasis).
Time frame: Up to 24 months from randomization
Pathological outcomes of second transurethral resection (re-TURBT)
Proportion of patients with residual tumor, upstaging (higher T category at re-TURBT), or concomitant CIS among those undergoing repeat TURBT.
Time frame: Perioperative (day of repeat TURBT)
Patient-reported outcomes
Health outcomes directly reported by the patient without interpretation by clinicians or others. These measures capture patients' perceptions of symptoms, functional status, health-related quality of life (HRQoL), and treatment-related burden.
Time frame: Up to 24 months from randomization.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.