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

N/AActive Not RecruitingNCT07252297

Xijing Hospital177 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

177

Conditions

Non-muscle Invasive Bladder Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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 -

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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