Non-muscle Invasive Bladder CancerNMIBCNCT07252297
The Role of Universal Cancer Only Marker SIX6 in Diagnosing Non-Muscle Invasive Bladder Cancer
A study testing SIX6 Gene Methylation Assay in people with Non-muscle Invasive Bladder Cancer, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer
- What is being tested?
- SIX6 Gene Methylation Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age higher than 18;
- patients diagnosis with non muscle invisive bladder cancer;
- willing to provide 100Ml urine before treatment;
- patients were diagnosis with bladder cancer for the first time
Who cannot join
- patiens have more than one tumors besides bladder cancer;
- pregnant women;
- unwilling to partipate the research -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of SIX6 as a Universal Cancer Marker in the Diagnosis of Non-Muscle Invasive Bladder Cancer
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
- Non-muscle Invasive Bladder Cancer
- Being tested
- SIX6 Gene Methylation Assay
- Keywords
- DNA methylation;, biomarker, diagnosis
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIX6 Gene Methylation AssayDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| SIX6 Positive | Experimental | 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. Receives: Diagnostic Test: SIX6 Gene Methylation Assay |
| SIX6 Methylation Negative | Experimental | 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. Receives: Diagnostic Test: SIX6 Gene Methylation Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of initial TURBT surgery (baseline)
Secondary outcomes (1)
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.
Measured: Through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start18 Mar 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252297
- Sponsor's protocol ID
- XJLL-KY-20252509
- Other IDs
- 2024JC-YBQN-0984
- Acronym
- NMIBC
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of SIX6 as a Universal Cancer Marker in the Diagnosis of Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07252297
- Acronym / sponsor ID
- NMIBC / XJLL-KY-20252509
- Conditions
- Non-muscle Invasive Bladder Cancer
- Keywords
- DNA methylation;, biomarker, diagnosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SIX6 Positive | Experimental | Diagnostic Test: SIX6 Gene Methylation AssayParticipants 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. |
| SIX6 Methylation Negative | Experimental | Diagnostic Test: SIX6 Gene Methylation AssayParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age higher than 18;
- patients diagnosis with non muscle invisive bladder cancer;
- willing to provide 100Ml urine before treatment;
- patients were diagnosis with bladder cancer for the first time
Key exclusion criteria (3 listed)
- patiens have more than one tumors besides bladder cancer;
- pregnant women;
- unwilling to partipate the research -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIX6 Gene Methylation AssayA 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. | Diagnostic test | SIX6 Methylation Negative, SIX6 Positive |
Primary outcome
Difference in SIX6 methylation levels between recurrence and non-recurrence groups
Time frame: 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.
1 secondary outcome
Diagnostic performance of SIX6 methylation for predicting recurrence
Time frame: Through study completion, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIX6 Gene Methylation Assay in people with Non-muscle Invasive Bladder Cancer, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in SIX6 methylation levels between recurrence and non-recurrence groups (time frame: At the time of initial TURBT surgery (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.