An interventional study of SIX6 Gene Methylation Assay in Non-muscle Invasive Bladder Cancer, sponsored by Xijing Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Diagnostic
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.
265 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 113 are open to participants now.
This study's planned enrollment of 177 is above the median of 70 across 204 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
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Exclusion Criteria:
Participants with low-risk NMIBC who test positive for SIX6 gene methylation in their post-operative tissue or urine sample. This cohort is observed prospectively for the outcome of tumor recurrence.
Diagnostic Test: SIX6 Gene Methylation Assay
Participants with low-risk NMIBC who test negative for SIX6 gene methylation in their post-operative tissue or urine sample. This cohort serves as the control and is observed prospectively for the outcome of tumor recurrence.
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.
Difference in SIX6 methylation levels between recurrence and non-recurrence groups
SIX6 gene promoter methylation level is measured as a continuous variable from post-operative tissue or urine DNA using quantitative methylation-specific PCR (qMSP). The values will be compared between the group of patients who later experience recurrence and the group who do not.
Time frame: At the time of initial TURBT surgery (baseline)
Diagnostic performance of SIX6 methylation for predicting recurrence
The predictive performance will be assessed by calculating the Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and the Area Under the Receiver Operating Characteristic Curve (AUC-ROC) for the primary outcome of histologically confirmed tumor recurrence.
Time frame: Through study completion, up to 3 years
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Xijing Hospital