NCT07252297

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

The Role of SIX6 as a Universal Cancer Marker in the Diagnosis of Non-Muscle Invasive Bladder Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SIX6 Gene Methylation Assay	A molecular diagnostic test that detects the methylation status of the SIX6 gene promoter region in post-operative tissue or urine samples from patients with low-risk non-muscle-invasive bladder cancer (NMIBC). The test uses quantitative methylation-specific PCR to determine methylation levels, which are then used to classify patients into SIX6 methylation positive or negative groups for prognostic assessment of recurrence risk.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: China