The Guiding Value of Liquid Biopsy Based on Urinary Tumor DNA/RNA in the Second Transurethral Resection of High-risk Non-muscle Invasive Bladder Cancer

Launched by TIANJIN MEDICAL UNIVERSITY SECOND HOSPITAL · Aug 12, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help decide if patients with a certain type of early-stage bladder cancer, called high-risk non-muscle-invasive bladder cancer, really need a second surgery after their initial tumor removal. Usually, doctors recommend a second surgery called re-TURBT within a few weeks to make sure all the cancer is gone and to get more information about the tumor. However, this second surgery might not always be necessary and can come with risks and added costs. This study is testing whether a simple urine test, which looks for tiny pieces of tumor DNA or RNA (genetic material from the cancer) in the urine, can help doctors better identify who truly needs this second surgery.

People eligible for this study are adults diagnosed with this type of bladder cancer who have had their first tumor removal but might still have leftover cancer or uncertain results from that surgery. Participants will provide a urine sample a few weeks after their first surgery to check for tumor DNA/RNA and may also give tissue samples from their tumor. The goal is to see if this urine test can safely reduce the number of second surgeries, so patients avoid unnecessary procedures while still effectively managing their cancer. The study is currently looking for volunteers aged 18 and older, regardless of gender.

Gender

ALL

Eligibility criteria

• 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.
• • 8. Voluntarily agrees to participate in the study, has signed informed consent, demonstrates good compliance, and is willing to complete study follow-up.
• Exclusion Criteria:
• • 1. Contraindications to transurethral resection of bladder tumor (TURBT).
• • 2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).