A Multicenter, Single-blind, Observational Clinical Trial of URISAFE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 482
- 试验地点
- 1
- 主要终点
- Specificity
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Specificity
时间窗: One year
Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
Consistency Rate
时间窗: One year
Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
Sensitivity
时间窗: One year
Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
Kappa Coefficient
时间窗: One year
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.
次要结局
未报告次要终点