DNA Methylation for Screening Uterine Cervical Lesions

Lei Li

Status: Unknown

Conditions: DNA Methylation; Low Grade Squamous Intraepithelial Lesions; High Grade Squamous Intraepithelial Lesions; Uterine Cervical Cancer

Treatments: Diagnostic Test: High-risk HPV; Diagnostic Test: DNA methylation; Diagnostic Test: TCT

Study type: Observational

Funder types: Other

Identifiers

NCT03960879

METHY2

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed cervical histology within one month when collecting cervical cytology
• Aged 18 years or older
• Signed an approved informed consents

Exclusion criteria

• Not meeting all of the inclusion criteria