NCT05337189

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

A Multicenter, Single-blind, Observational Clinical Trial of URISAFE

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 482 (estimated)
• Sponsor: Creative Biosciences (Guangzhou) Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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).

Detailed description

In this clinical trial, the testing kit to be evaluated is a Human Multigene Methylation Detection Kit (Fluorescent PCR Method), which is intended to qualitatively detect methylation levels of multiple genes in human urine specimen in vitro by Fluorescent PCR Method, and the standard method used in clinical diagnostic includes medical imaging, cystoscopy, pathological examination. Subjects will provided urine specimen as required for the evaluation of the testing kit followed by a examination of standard method. Technical personnel who conduct the evaluation of the testing kit will remain blinded to the results of the clinical diagnosis. The results of the testing kit will be compared with the standard method, and the effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for bladder cancer detection under normal clinical use will be assessed through statistical analysis.

Conditions

• Bladder Cancer
• Urocystitis
• Urinary Bladder Stone
• Urothelial Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Urine DNA methylation analysis	Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)
PROCEDURE	medical imaging and/or cystoscopy and/or pathological examination	Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination

Timeline

• Start date: 2022-03-09
• Primary completion: 2025-04-15
• Completion: 2025-04-30
• First posted: 2022-04-20
• Last updated: 2025-02-13

Locations

1 site across 1 country: China