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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: DNA methylation
* Diagnostic Test: high-risk HPV
* Diagnostic Test: TCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |