NCT05290922

DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening

The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 7,150 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for endometrial screening. Four 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 CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 7150 patients.

Conditions

• Endometrial Cancer
• Cancer Screening
• DNA Methylation
• Testing Accuracy
• Cervical Cytology

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DNA methylation testing	The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation.

Timeline

• Start date: 2022-03-12
• Primary completion: 2022-09-12
• Completion: 2023-03-12
• First posted: 2022-03-22
• Last updated: 2022-03-22

Locations

1 site across 1 country: China