DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening
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About
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.
Enrollment
Sex
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Volunteers
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
Trial design
459 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Lie Li, M.D.
Data sourced from clinicaltrials.gov
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