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NCT07252297Active, not recruiting

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 · Last updated 4 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
177 (estimated)
First submitted
18 Nov 2025
Start date
18 Mar 2025
Primary completion date
30 Dec 2026
Lead sponsor
Xijing Hospital
NCT number
NCT07252297

What you commit to

  • Study type: Interventional
  • Planned participants: 177
  • From 18 Mar 2025 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • patiens have more than one tumors besides bladder cancer;

Other

  • pregnant women;
  • unwilling to partipate the research -

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xi Jing Hopspital
Coordinator of this site? Confirm its status
Xi'anChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.