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

• Conditions: High Grade Squamous Intraepithelial Lesions; Low Grade Squamous Intraepithelial Lesions; DNA Methylation; Uterine Cervical Cancer
• Interventions: Diagnostic Test: DNA methylation; Diagnostic Test: high-risk HPV; Diagnostic Test: TCT

• Registration Number: NCT03961191
• Lead Sponsor: Lei Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-21
• Study Start: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-23
• Primary Completion: 2020-05-22
• Study Completion: 2020-05-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benign group	high-risk HPV	Patients with benign cervical histology, including normal findings, inflammation and LSIL
Benign group	TCT	Patients with benign cervical histology, including normal findings, inflammation and LSIL
Cancer group	TCT	Patients with cervical histology of cancer
Benign group	DNA methylation	Patients with benign cervical histology, including normal findings, inflammation and LSIL
Cancer group	DNA methylation	Patients with cervical histology of cancer
HSIL group	DNA methylation	Patients with cervical histology of HSIL
HSIL group	high-risk HPV	Patients with cervical histology of HSIL
HSIL group	TCT	Patients with cervical histology of HSIL
Cancer group	high-risk HPV	Patients with cervical histology of cancer

Primary Outcome Measures

Name	Time	Method
Specificity of DNA methylation	1 years	Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Sensitivity of DNA methylation	1 years	Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

Secondary Outcome Measures

Name	Time	Method
Negative predictive value of DNA methylation	1 year	Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Correlation coefficient of DNA methylation with other screening methods	1 year	Correlation coefficient of DNA methylation with high-risk HPV and TCT results
Positive predictive value of DNA methylation	1 year	Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China