In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12,000
Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample
Cervical cytology and/or high-risk human papillomavirus assays
Lei Li
Beijing, Beijing Municipality, China
RECRUITINGDiagnostic accuracy
The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Time frame: Two years
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