RecruitingNCT05337189

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

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


Sponsor

Creative Biosciences (Guangzhou) Co., Ltd.

Enrollment

482 participants

Start Date

Mar 9, 2022

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a urine-based DNA test to detect bladder cancer, aiming to see how well it works compared to traditional methods like cystoscopy (a camera procedure inside the bladder). **You may be eligible if...** - You are willing to sign an informed consent form - You have been diagnosed with or are suspected of having bladder cancer - You have high-risk factors for bladder cancer (occupational chemical exposure, smoking, family history, etc.) - You are experiencing blood in the urine or other urinary symptoms - You are undergoing or have had cystoscopy or imaging for bladder concerns **You may NOT be eligible if...** - You are unwilling to participate or sign consent - You cannot provide a urine sample Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTUrine DNA methylation analysis

Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)

PROCEDUREmedical 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

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NCT05337189


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