Non-Muscle-Invasive Bladder Cancer (NMIBC)
Conditions
Interventions
Control Group:Repeat TURBT was performed within 8–12 weeks after the initial resection. Patients with negative pathological findings will undergo follow?up examinations every 3 months, including cysto
Intervention group:Patients with a positive utDNA MRD test result underwent repeat TURBT, whereas those with a negative result did not receive repeat resection.
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older with clinically confirmed intermediate- to high-risk non-muscle-invasive bladder cancer (NMIBC). 2. Histologically confirmed as urothelial carcinoma. 3. Patients with NMIBC who met the guideline-recommended indications for repeat TURBT; 4. A 100 mL morning urine sample (first void) is required at each designated time point.
Exclusion criteria
Exclusion criteria: 1.Patients with confirmed residual tumor at the initial TURBT. 2.Patients who had been enrolled in any drug clinical trial within 3 months before study entry. 3.Any condition that, in the judgment of the investigator, could potentially increase the risk to the participant or compromise the execution of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the pathological positive rate of Re-TURBT between the study group and the control group (i.e., an increase in the positive rate of repeat resection;The difference in the disease-free rate at 3 months post-intervention between the study group (utDNA MRD testing) and the control group (routine surveillance) was assessed as the primary endpoint ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The disease recurrence rates at 6 and 12 months after intervention ;The sensitivity and specificity of urinary utDNA MRD testing.;The difference in total costs for the diagnosis and treatment of NMIBC.; | — |
Countries
China
Contacts
Public ContactPengjie Wu
Beijing Hospital
Outcome results
None listed