Spots Global Cancer Trial Database for DNA Methylation for Screening Uterine Cervical Lesions
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Trial Identification
Brief Title: DNA Methylation for Screening Uterine Cervical Lesions
Official Title: DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort Study
Study ID: NCT03960879
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Lei Li, Beijing, Beijing, China
Contact Details
Name: Lei Li, M.D.
Affiliation: Peking Union Medical College Hospital
Role: PRINCIPAL_INVESTIGATOR
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