DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

  • STATUS
    Recruiting
  • days left to enroll
    11
  • participants needed
    459
  • sponsor
    Peking Union Medical College Hospital
Updated on 5 April 2022
cancer
hysterectomy
cancer screening
diagnostic procedures
cervical cancer screening
cone biopsy
loop electrosurgical excision procedure

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.

Details
Condition Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation, Cancer Screening, Detection Accuracy
Treatment DNA methylation testing
Clinical Study IdentifierNCT05290428
SponsorPeking Union Medical College Hospital
Last Modified on5 April 2022

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