Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.
Study Type
OBSERVATIONAL
Enrollment
459
All cervical cytology samples will be tested for PAX1 and JAM3 methylation
Lei Li
Beijing, Beijing Municipality, China
RECRUITINGSensitivity of methylation testing
Sensitivity of methylation testing of cervical cytology compared with histology
Time frame: One week
Specificity of methylation testing
Specificity of methylation testing of cervical cytology compared with histology
Time frame: One week
Positive predictive value of methylation testing
Positive predictive value of methylation testing of cervical cytology compared with histology
Time frame: One week
Negative predictive value of methylation testing
Negative predictive value of methylation testing of cervical cytology compared with histology
Time frame: One week
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