Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening in a multi-center cohort. Thirteen 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 CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 10,000 patients.
Study Type
OBSERVATIONAL
Enrollment
10,000
DNA CDO1 and CELF4 methylation testing
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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