Clinical Trial

The Role of Universal Cancer Only Marker SIX6 in Diagnosing Non-Muscle Invasive Bladder Cancer

Study acronym: NMIBC
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Transurethral resection of bladder tumor (TURBT) is the standard therapeutic approach for patients with non-muscle-invasive bladder cancer (NMIBC). Postoperative intravesical chemotherapy or BCG immunotherapy is commonly administered to prevent recurrence. However, limitations such as suboptimal specimen integrity and tissue artifacts from intraoperative cauterization may lead to inaccurate risk stratification in cases classified as low-risk NMIBC, complicating individualized prognostic assessment. Consequently, clinicians often resort to prolonged intravesical therapy to mitigate recurrence risk, resulting in substantial overtreatment. Previous studies in bladder cancer have demonstrated that detection of SIX6 gene methylation in urine enables noninvasive and accurate auxiliary diagnosis, with a sensitivity of 88.9%, specificity of 94.7%, and overall accuracy of 92.9%. In this retrospective case-control study, we aim to evaluate the utility of SIX6 methylation as an objective biomarker for predicting recurrence in patients with low-risk NMIBC.
Trial Details
NCT Number NCT07252297
Lead Sponsor Xijing Hospital
Conditions Non-muscle Invasive Bladder Cancer
Enrollment 177 participants
Start Date 2024-01-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-26