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 lung cancer by comparing with clinical standard method (includes chest CT examination or 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 sputum specimen in vitro by Fluorescent PCR Method, and the standard method used in clinical diagnosis is chest CT examination or pathological examination. Subjects will provided sputum specimen as required for the evaluation of the testing kit followed by a chest CT examination or pathological examination. Technical personnel who conduct the evaluation of the testing kit will remain blinded to the results of the clinical diagnosis by chest CT and/or pathological examination. 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 lung cancer detection under normal clinical use will be assessed through statistical analysis.
Study Type
OBSERVATIONAL
Enrollment
1,564
Diagnostic Test: sputum specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)
Subjects will undergo chest CT or pathological examination.
Nanfang Hospital of Southern Medccal University
Guangzhou, Guangdong, China
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
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