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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05290428
Study type Observational
Source Peking Union Medical College Hospital
Contact Lie Li, M.D.
Phone 10-139-1198-8831
Email lileigh@163.com
Status Recruiting
Phase
Start date March 12, 2022
Completion date December 12, 2022

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