The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study. This study will include 300 unselected patients with definite histological results. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed. The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.
Study Type
OBSERVATIONAL
Enrollment
300
DNA methylation for the cervical cytology
High-risk HPV testing for the cervical cytology
Thin prep liquid-based cytology test for the cervical cytology
Lei Li
Beijing, Beijing Municipality, China
RECRUITINGSensitivity of DNA methylation
Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL)
Time frame: 1 year
Specificity of DNA methylation
Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Time frame: 1 year
Positive predictive value of DNA methylation
Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Time frame: 1 year
Negative predictive value of DNA methylation
Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Time frame: 1 year
Correlation coefficient of DNA methylation with other screening methods
Correlation coefficient of DNA methylation with high-risk HPV and TCT results
Time frame: 1 year
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