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All Genders
Healthy Volunteers
ID05337189

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

Led by Creative Biosciences (Guangzhou) Co., Ltd. · Updated on 2025-02-13

482

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

Sponsors

C

Creative Biosciences (Guangzhou) Co., Ltd.

Lead Sponsor

G

Guangzhou Xiangkang Medical Research Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Brief Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:

  • Subject must meet all three of the following criteria to be eligible for the study:

    1. Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form;

    2. Who is willing to undergo or has completed medical imaging and/or cystoscopy and/or pathological examination;

    3. Any subject who is required to meet any of the following conditions:

      1. Who is diagnosed with or suspected of bladder cancer.
      2. Who has high risk factors for bladder cancer (such as engaged in contact with aromatic amines, dyes, rubber, aluminum, leather and other occupations, schistosomiasis infection, family genetic history, smoking, drinking, etc.).
      3. Who has hematuria symptoms (such as cystitis, stones, etc.).
      4. Who has other diseases that can be easily confused with bladder cancer.

Exclusion Criteria:

  • Subject with any of the following conditions shall be excluded:

    1. Who has undergone surgery or chemoradiotherapy.
    2. Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.

Research Team

X

Xianshu Wang, PhD

C

Chunhua Chen

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