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| Name | Class |
|---|---|
| Zhejiang Provincial People's Hospital | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective part | This part will enroll at least 120 cases in previously preserved samples. |
| |
| Prospective part | This part will enroll at least 339 cases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA methylation testing | Diagnostic Test | All cervical cytology samples will be tested for PAX1 and JAM3 methylation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All participants will accept surgeries harvesting cervical histology.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lie Li, M.D. | Contact | 10-139-1198-8831 | lileigh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Cervical cytology
Negative predictive value of methylation testing of cervical cytology compared with histology
| One week |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |