A Multicenter, Single-blind, Observational Clinical Trial of URISAFE for Bladder Cancer Diagnosis

What this Trial Is About

Researchers are evaluating the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) to help diagnose bladder cancer by comparing it with standard clinical methods such as medical imaging, cystoscopy, and pathological examination. The study includes participants diagnosed with or suspected of bladder cancer, those at high risk, or those with symptoms or other conditions that might be confused with bladder cancer. The goal is to assess the safety and effectiveness of this urine DNA testing kit. Participants will provide urine specimens for testing with the Human Multigene Methylation Detection Kit, and will also undergo examinations using the standard clinical methods. The study involves two groups of participants: one with bladder cancer and one without. Technical staff evaluating the urine test results will be blinded to the clinical diagnosis results. The study is observational and single-blinded. During the study, participants will provide urine samples and undergo medical imaging, cystoscopy, or pathological examination as needed. Researchers will compare the urinary test results with clinical findings to analyze sensitivity, specificity, consistency rate, and agreement (Kappa Coefficient) over one year. Participants' involvement includes specimen collection and standard diagnostic procedures, with safety and diagnosis effectiveness monitored throughout the study period.

A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China