The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have tested negative on a urine biomarker test can safely skip a second surgery called transurethral resection (reTURBT). The main goal is to see if avoiding this additional surgery will still allow patients to have a good chance of not having their cancer return. In the study, participants who have already had their initial surgery and received a negative urine test will be divided into two groups: one group will not have the second surgery, while the other group will undergo it. Researchers will then compare the rates of cancer recurrence between the two groups.

To be eligible for this trial, participants must be at least 18 years old, have already had their first surgery for NMIBC, and have tested negative for the urine biomarker. They will need to agree to provide some basic health information and sign a consent form. This study is currently recruiting participants, and it offers an opportunity for patients to help determine if the urine test can help avoid unnecessary surgeries, potentially making their treatment experience easier.

Gender

ALL

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.