Evaluating the need for repeat bladder surgery in patients with negative urine biomarker tests

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

This study is testing if patients with non-muscle-invasive bladder cancer who have negative urine biomarker tests can skip repeat bladder surgery and still do well.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 428 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06287541 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether patients with non-muscle-invasive bladder cancer (NMIBC) who test negative for urine biomarkers can safely avoid a repeat transurethral resection of bladder tumor (reTURBT). Participants who have undergone an initial TURBT will be randomized into two groups: one group will not receive reTURBT, while the other will undergo the procedure. The study aims to compare recurrence-free survival rates between the two groups to determine if the urine biomarker test can effectively guide treatment decisions. The trial adheres to ethical guidelines and maintains participant confidentiality throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with NMIBC who have tested negative for urine biomarkers after initial TURBT.

Not a fit: Patients with muscle-invasive bladder cancer or those unable to undergo a second transurethral resection will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help patients avoid unnecessary surgeries while maintaining their cancer management effectively.

How similar studies have performed: While there have been studies on urine biomarkers in bladder cancer, this specific approach to guiding reTURBT decisions is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Qiang Lv, Ph.D

Conditions: Non Muscle Invasive Bladder Cancer, reTURBT, NMIBC, urine biomarker, RFS