DNA Methylation for Screening Uterine Cervical Lesions

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

• Registration Number: NCT03960879
• 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-21
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-24
• Study Start: 2019-06-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01

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 all of the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of DNA methylation	1 year	Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL)
Specificity of DNA methylation	1 year	Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China