Cancer Screening, Cervical Cancer, Cervical Intraepithelial Neoplasia, Detection Accuracy, DNA Methylation
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTDNA methylation testing
All cervical cytology samples will be tested for PAX1 and JAM3 methylation
Sponsors
Zhejiang Provincial People's Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of methylation testing | One week | Sensitivity of methylation testing of cervical cytology compared with histology |
| Specificity of methylation testing | One week | Specificity of methylation testing of cervical cytology compared with histology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative predictive value of methylation testing | One week | Negative predictive value of methylation testing of cervical cytology compared with histology |
| Positive predictive value of methylation testing | One week | Positive predictive value of methylation testing of cervical cytology compared with histology |
Countries
China
Contacts
Primary ContactLie Li, M.D.
Outcome results
None listed