Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIX6 Gene Methylation Assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SIX6 Positive
- 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.
- interventionNames
- Diagnostic Test: SIX6 Gene Methylation Assay
- type
- EXPERIMENTAL
- label
- SIX6 Methylation Negative
- 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.
- interventionNames
- Diagnostic Test: SIX6 Gene Methylation Assay
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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 -
References
Publications (0)
Data not yet available