|

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

RECRUITINGN/ASponsored by The First Affiliated Hospital with Nanjing Medical University
Actively Recruiting
PhaseN/A
SponsorThe First Affiliated Hospital with Nanjing Medical University
Started2023-07-01
Est. completion2025-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerNon-Muscle Invasive Bladder Cancer

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.