Cervical Cancer, Cervical Intraepithelial Neoplasia, Cytology, DNA Methylation, High-risk Human Papillomavirus
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTHost DNA methylation testing
Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample
DIAGNOSTIC_TESTCervical cytology and/or high-risk human papillomavirus assays
Cervical cytology and/or high-risk human papillomavirus assays
Sponsors
Lei Li
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 21 years or older * Signed an approved informed consents * Feasible to be followed up * Available residual cytology samples for methylation analysis
Exclusion criteria
* Without history of cervical disease, including cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+) * No requirement of cervical cancer screening of cytology or high-risk human papillomavirus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | Two years | The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value. |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Outcome results
None listed