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

Utilization of DNA Methylation in the Screening of Uterine Cervical Lesions: A Case-control Study

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.

Study Overview

• Status: Unknown
• Conditions: DNA Methylation; Uterine Cervical Cancer; High Grade Squamous Intraepithelial Lesions; Low Grade Squamous Intraepithelial Lesions
• Intervention / Treatment: Diagnostic test: DNA methylation; Diagnostic test: TCT; Diagnostic test: high-risk HPV

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

1. Wtih confirmed cervical histology within one month when collecting cervical cytology
2. Aged 18 years or older

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Benign group; Patients with benign cervical histology, including normal findings, inflammation and LSIL	Diagnostic test: DNA methylation; DNA methylation for the cervical cytology; Diagnostic test: TCT; Thin prep liquid-based cytology test for the cervical cytology; Diagnostic test: high-risk HPV; High-risk HPV testing for the cervical cytology
HSIL group; Patients with cervical histology of HSIL	Diagnostic test: DNA methylation; DNA methylation for the cervical cytology; Diagnostic test: TCT; Thin prep liquid-based cytology test for the cervical cytology; Diagnostic test: high-risk HPV; High-risk HPV testing for the cervical cytology
Cancer group; Patients with cervical histology of cancer	Diagnostic test: DNA methylation; DNA methylation for the cervical cytology; Diagnostic test: TCT; Thin prep liquid-based cytology test for the cervical cytology; Diagnostic test: high-risk HPV; High-risk HPV testing for the cervical cytology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of DNA methylation	Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL	1 years
Specificity of DNA methylation	Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL	1 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lei Li

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Anticipated): May 22, 2020
• Study Completion (Anticipated): May 22, 2020

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms; Squamous Intraepithelial Lesions of the Cervix
• Other Study ID Numbers: METHY1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No