NCT05290428

DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

The Accuracy of Host DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 459 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• DNA Methylation
• Cancer Screening
• Detection Accuracy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DNA methylation testing	All cervical cytology samples will be tested for PAX1 and JAM3 methylation

Timeline

• Start date: 2022-03-12
• Primary completion: 2022-09-12
• Completion: 2022-12-12
• First posted: 2022-03-22
• Last updated: 2022-03-22

Locations

1 site across 1 country: China