Status:
RECRUITING
A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China
Lead Sponsor:
Creative Biosciences (Guangzhou) Co., Ltd.
Collaborating Sponsors:
Guangzhou Xiangkang Medical Research Co., Ltd.
Conditions:
Bladder Cancer
Urocystitis
Eligibility:
All Genders
Brief 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 c...
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 multipl...
Eligibility Criteria
Inclusion
- Subject must meet all three of the following criteria to be eligible for the study:
- Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form;
- Who is willing to undergo or has completed medical imaging and/or cystoscopy and/or pathological examination;
- Any subject who is required to meet any of the following conditions:
- Who is diagnosed with or suspected of bladder cancer.
- 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.).
- Who has hematuria symptoms (such as cystitis, stones, etc.).
- Who has other diseases that can be easily confused with bladder cancer.
Exclusion
- Subject with any of the following conditions shall be excluded:
- Who has undergone surgery or chemoradiotherapy.
- Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT05337189
Start Date
March 9 2022
End Date
April 30 2025
Last Update
February 13 2025
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China