A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether some patients with a certain type of early-stage bladder cancer (called non-muscle-invasive bladder cancer) really need to have a second surgery after their first tumor removal. Usually, after the initial surgery to remove the bladder tumor, doctors recommend a second surgery to make sure no cancer is left behind. This study uses a special urine test that looks at the DNA from cancer cells to see if any cancer might still be present. If the test shows no signs of cancer, some patients may be able to skip the second surgery, while others will still have it, so researchers can compare how well patients do with or without the second surgery.

People who might join the study are adults who have had their first bladder tumor surgery but are considered high risk for leftover cancer, based on their initial results or tumor features. Participants will provide a urine sample a few weeks after the first surgery, which will be tested for cancer DNA. Depending on the test results, patients will either have the second surgery or possibly avoid it. Everyone will be followed for two years to see if the cancer comes back and to help doctors understand if the urine test can safely guide treatment decisions. This study aims to help reduce unnecessary surgeries and improve care for bladder cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Patients with NMIBC who have completed the initial transurethral resection and are scheduled for a second resection, as recommended by guidelines or physician's choice:
• • 1. Incomplete initial TURBT due to various reasons (including large tumor size, high risk of intraoperative bleeding, extensive tumor range, etc.), posing a risk of residual tumor;
• • 2. Absence of muscle layer tissue in the initial resection specimen;
• • 3. Post-initial resection pathology indicating T1 stage;
• • 4. Post-initial resection pathology indicating G3/high-grade tumor, excluding pure carcinoma in situ;
• • Ability to provide a 100ml routine urine sample within 1-6 weeks after the initial resection and before the second resection;
• • Age ≥ 18 years;
• • Willingness to provide basic clinical information, pathology, and subsequent - recurrence monitoring results;
• • Willingness to sign the informed consent form.
• 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 resection;
• • Patients with incomplete pathological information of the sample;
• • Patients with contaminated samples;
• • Patients whose urine samples fail quality control for valid reasons and cannot be resampled;
• • Any condition deemed by the investigator as potentially harming the subject or preventing the subject from meeting or fulfilling the study requirements;
• • Patients unable to provide written informed consent.