DNA Methylation Testing for the Screening of Uterine Cervical Lesion

Lei Li

Status and phase

Unknown

Phase 3

Conditions

DNA Methylation

High-risk Human Papillomavirus

Cytology

Cervical Intraepithelial Neoplasia

Cervical Cancer

Treatments

Diagnostic Test: Host DNA methylation testing

Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays

Study type

Interventional

Funder types

Other

Identifiers

NCT04646954

METHY3

Details and patient eligibility

About

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.

Enrollment

12,000 estimated patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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