DNA Methylation Testing for the Screening of Uterine Cervical Lesion

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04646954
Study type	Interventional
Source	Peking Union Medical College Hospital
Contact	Lei Li, M.D.
Phone	+8613911988831
Email	lileigh@163.com
Status	Recruiting
Phase	Phase 3
Start date	November 26, 2020
Completion date	November 26, 2022

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