Clinical trial · Interventional
The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
A Prospective, Multicenter, Randomized Study Comparing the Necessity of a Second Transurethral Resection of Bladder Tumor in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Urine biomarker -Guided without reTURBT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Urine biomarker -Guided without reTURBT
- description
- Participants in this arm will proceed without reTURBT.
- interventionNames
- Procedure: Urine biomarker -Guided without reTURBT
- type
- NO_INTERVENTION
- label
- Standard Care with reTURBT
- description
- Participants in this arm will receive standard care, which undergo reTURBT
Primary outcomes (1)
- measure
- 2-year RFS rate
- timeFrame
- from initial TURBT to the first confirmed recurrence within 2 years
- description
- the proportion of participants experiencing a recurrence during follow-up within 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with NMIBC who have undergone initial TURBT and are scheduled for reTURBT surgery as recommended by guidelines or chosen by their physicians; * Patients who have tested negative for urine biomarkers after the initial TURBT and before the second TURBT; * Age ≥ 18 years; * Willingness to provide personal basic clinical information, as well as pathology and subsequent recurrence monitoring results; * Willingness to sign informed consent. Exclusion Criteria: * Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma); * Patients previously diagnosed with muscle-invasive bladder cancer; * Patients unable to undergo a second transurethral resection; * Patients with incomplete sample pathology information; * Any condition perceived by the researcher to potentially harm the subjects or prevent them from meeting or executing the study requirements; * Patients unable to provide written informed consent.
References
Publications (0)
Data not yet available