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A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China
Sponsor: Creative Biosciences (Guangzhou) Co., Ltd.
Summary
The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose bladder cancer by comparing with clinical standard method (includes medical imaging (MRI, CT, etc.), cystoscopy, pathological examination).
Official title: A Multicenter, Single-blind, Observational Clinical Trial of URISAFE
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
482
Start Date
2022-03-09
Completion Date
2025-04-30
Last Updated
2025-02-13
Healthy Volunteers
Yes
Interventions
Urine DNA methylation analysis
Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)
medical imaging and/or cystoscopy and/or pathological examination
Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination
Locations (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China