NCT03960879

DNA Methylation for Screening Uterine Cervical Lesions

DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• DNA Methylation
• Uterine Cervical Cancer
• High Grade Squamous Intraepithelial Lesions
• Low Grade Squamous Intraepithelial Lesions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DNA methylation	DNA methylation for the cervical cytology
DIAGNOSTIC_TEST	High-risk HPV	High-risk HPV testing for the cervical cytology
DIAGNOSTIC_TEST	TCT	Thin prep liquid-based cytology test for the cervical cytology

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2019-05-23
• Last updated: 2019-05-24

Locations

1 site across 1 country: China