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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
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Lei Li
Beijing, Beijing Municipality, China
Start Date
March 12, 2022
Primary Completion Date
September 12, 2022
Completion Date
December 12, 2022
Last Updated
March 22, 2022
459
ESTIMATED participants
DNA methylation testing
DIAGNOSTIC_TEST
Lead Sponsor
Peking Union Medical College Hospital
Collaborators
NCT06349642
NCT04712851
Data Source & Attribution
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