DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

Study Overview
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Brief Summary
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Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.

Official Title
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The Accuracy of Host DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials

Conditions
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Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation, Cancer Screening, Detection Accuracy

Intervention / Treatment
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* Diagnostic Test: DNA methylation testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With uterine cervix intact Aged 18 years or older With accessible histological results of cervix Signed an approved informed consents With accessible cervical cytology before harvesting cervical histology 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective part<br>This part will enroll at least 120 cases in previously preserved samples. | Diagnostic Test: DNA methylation testing<br>* All cervical cytology samples will be tested for PAX1 and JAM3 methylation<br>|
| Prospective part<br>This part will enroll at least 339 cases. | Diagnostic Test: DNA methylation testing<br>* All cervical cytology samples will be tested for PAX1 and JAM3 methylation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of methylation testing | Sensitivity of methylation testing of cervical cytology compared with histology | One week | 
| Specificity of methylation testing | Specificity of methylation testing of cervical cytology compared with histology | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of methylation testing | Positive predictive value of methylation testing of cervical cytology compared with histology | One week | 
| Negative predictive value of methylation testing | Negative predictive value of methylation testing of cervical cytology compared with histology | One week |