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

Air Force Military Medical University of People's Liberation Army

Status: Active, not recruiting

Conditions: Non-muscle Invasive Bladder Cancer

Treatments: Diagnostic Test: SIX6 Gene Methylation Assay

Study type: Interventional

Funder types: Other

Identifiers

NCT07252297

XJLL-KY-20252509

2024JC-YBQN-0984 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 177 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 2 patient groups

SIX6 Positive

Experimental group

Description:

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.

Treatment:

Diagnostic Test: SIX6 Gene Methylation Assay

SIX6 Methylation Negative

Experimental group

Description:

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.

Treatment:

Diagnostic Test: SIX6 Gene Methylation Assay