Detecting CREPT in Urine for Bladder Cancer Diagnosis and Monitoring

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07514897
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Study Details

This study will, for the first time, establish a non-invasive diagnostic model for bladder cancer based on CREPT expression levels in exfoliated urothelial cells using a multicenter cohort, and validate its value in the non-invasive diagnosis and recurrence monitoring of bladder cancer. Its high sensitivity is expected to overcome the technical limitations of existing biomarkers and provide an innovative solution for establishing an integrated precision diagnosis and treatment system encompassing "screening, diagnosis, and monitoring."

Key Dates

First listed
Apr 7, 2026
Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Patients diagnosed with or suspected of having bladder cancer.
    After collecting 50 ml of the second morning urine, the expression of CREPT in urinary exfoliated cells was detected.

Primary Outcome Measure

Discrimination of the diagnostic model [ Time Frame: Short-term follow-up for 6 months, with follow-ups conducted at 3 months and 6 months post-enrollment; long-term follow-up for 1 year, with an additional follow-up at 12 months post-enrollment. ]

Central Contacts

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