DNA Methylation Testing for the Screening of Uterine Cervical Lesion

Study Overview
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Brief Summary
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In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

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

Conditions
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Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation, High-risk Human Papillomavirus, Cytology

Intervention / Treatment
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* Diagnostic Test: Host DNA methylation testing
* Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 21 years or older Signed an approved informed consents Feasible to be followed up Available residual cytology samples for methylation analysis Exclusion Criteria: Without history of cervical disease, including cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+) No requirement of cervical cancer screening of cytology or high-risk human papillomavirus

Ages Eligible for Study
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Minimum Age: 21 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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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>All eligible participants are included in the study group | Diagnostic Test: Host DNA methylation testing<br>* Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample<br>Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays<br>* Cervical cytology and/or high-risk human papillomavirus assays<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value. | Two years |