A Phase 3 interventional study of Host DNA methylation testing and Cervical cytology and/or high-risk human papillomavirus assays in Cervical Cancer, Cervical Intraepithelial Neoplasia and DNA Methylation, sponsored by Lei Li. Status unknown at 1 site in China. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-11-30.
Sponsored by Lei Li · Phase 3, Interventional, and Diagnostic
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.
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's planned enrollment of 12,000 is above the median of 166 across 249 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Lei Li is the lead sponsor of 60 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
All eligible participants are included in the study group
Diagnostic Test: Host DNA methylation testing · Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays
Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample
Cervical cytology and/or high-risk human papillomavirus assays
Diagnostic accuracy
The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Time frame: Two years
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Lei Li