Uterine Cervical Cancer Clinical Trial
Official title:
DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort Study
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.
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