DNA Methylation for Screening Uterine Cervical Lesions: A Case-control Study

Lei Li

Status: Unknown

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT03961191

METHY1

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 in a case-control study, so as to determine the accuracy of DNA methylation in the screening of uterine cervical lesions.

This study will include 300 patients with definite histological results, with 100 of cervical inflammation or low grade squamous intraepithelial lesions (LSIL), 100 of high grade squamous intraepithelial lesions (HSIL), and 100 of uterine cervical cancer. 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 any of the inclusion criteria

Trial design

300 participants in 3 patient groups

Benign group

Description:

Patients with benign cervical histology, including normal findings, inflammation and LSIL

Treatment:

Diagnostic Test: high-risk HPV

Diagnostic Test: TCT

Diagnostic Test: DNA methylation

HSIL group

Description:

Patients with cervical histology of HSIL

Treatment:

Diagnostic Test: high-risk HPV

Diagnostic Test: TCT

Diagnostic Test: DNA methylation

Cancer group

Description:

Patients with cervical histology of cancer

Treatment:

Diagnostic Test: high-risk HPV

Diagnostic Test: TCT

Diagnostic Test: DNA methylation