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

Creative Biosciences (Guangzhou) Co., Ltd.482 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

482

Conditions

Bladder Cancer Urocystitis Urinary Bladder Stone Urothelial Carcinoma

Interventions

Urine DNA methylation analysisDIAGNOSTIC_TEST

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

medical imaging and/or cystoscopy and/or pathological examinationPROCEDURE

Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Sensitivity

Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.

Time frame: One year

Specificity

Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.

Time frame: One year

Consistency Rate

Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.

Time frame: One year

Kappa Coefficient

Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.

Time frame: One year

Central Contacts

Xianshu Wang, PhD

CONTACT

86-01-18819269978 xianshuwang@creativebio.cn

Chunhua Chen

CONTACT

86-01-13560141654 chenchunhua@creativebio.cn

Data from ClinicalTrials.gov

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