DNA Methylation for Screening Uterine Cervical Lesions

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 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.

Official Title
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DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort 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 all 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

| Intervention/Treatment |
| --- |
|Diagnostic Test: DNA methylation|DNA methylation for the cervical cytology|
|Diagnostic Test: High-risk HPV|High-risk HPV testing for the cervical cytology|
|Diagnostic Test: TCT|Thin prep liquid-based cytology test for the cervical cytology|

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

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 |