Non-muscle Invasive Bladder Cancer
Conditions
Keywords
DNA methylation;, biomarker, diagnosis
Brief 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.
Interventions
DIAGNOSTIC_TESTSIX6 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.
Sponsors
Xijing Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This is a biomarker-based diagnostic study where participant grouping is determined by objective laboratory testing (SIX6 methylation status). Blinding of participants or investigators is not feasible due to the nature of the diagnostic assay.
Intervention model description
This study employs a parallel group design comparing two naturally occurring cohorts defined by SIX6 methylation status (positive vs. negative) in low-risk NMIBC patients, with prospective follow-up for recurrence outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. age higher than 18; 2. patients diagnosis with non muscle invisive bladder cancer; 3. willing to provide 100Ml urine before treatment; 4. patients were diagnosis with bladder cancer for the first time
Exclusion criteria
1. patiens have more than one tumors besides bladder cancer; 2. pregnant women; 3. unwilling to partipate the research -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in SIX6 methylation levels between recurrence and non-recurrence groups | At the time of initial TURBT surgery (baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of SIX6 methylation for predicting recurrence | Through study completion, up to 3 years | 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. |
Countries
China
Outcome results
None listed