A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China
Study Details
Study Description
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 clinical standard method (includes medical imaging (MRI, CT, etc.), cystoscopy, pathological examination).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Bladder cancer group Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting urine specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) test, eligible subjects also need to undergo the examination of standard method. |
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)
Other Names:
Procedure: medical imaging and/or cystoscopy and/or pathological examination
Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination
|
| The normal group Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting urine specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) test, eligible subjects also need to undergo the examination of standard method. |
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)
Other Names:
Procedure: medical imaging and/or cystoscopy and/or pathological examination
Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination
|
Outcome Measures
Primary Outcome Measures
- Sensitivity [One year]
Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
- Specificity [One year]
Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
- Consistency Rate [One year]
Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
- Kappa Coefficient [One year]
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subject must meet all three of the following criteria to be eligible for the study:
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Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form;
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Who is willing to undergo or has completed medical imaging and/or cystoscopy and/or pathological examination;
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Any subject who is required to meet any of the following conditions:
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Who is diagnosed with or suspected of bladder cancer.
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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.).
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Who has hematuria symptoms (such as cystitis, stones, etc.).
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Who has other diseases that can be easily confused with bladder cancer.
Exclusion Criteria:
- Subject with any of the following conditions shall be excluded:
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Who has undergone surgery or chemoradiotherapy.
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Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Cancer Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- Creative Biosciences (Guangzhou) Co., Ltd.
- Guangzhou Xiangkang Medical Research Co., Ltd.
Investigators
- Principal Investigator: Peng Du, PhD, Peking University Cancer Hospital & Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KLM2021-04