NCT05290415

Host DNA Methylation for Endometrial Cancer Screening

The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 in a multi-center cohort. Thirteen 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 10,000 patients.

Conditions

• Cancer Screening
• Endometrial Cancer
• DNA Methylation
• Cervical Cytology
• Liquid Biopsy
• Cohort Study

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DNA methylation testing	DNA CDO1 and CELF4 methylation testing

Timeline

• Start date: 2022-03-13
• Primary completion: 2022-06-13
• Completion: 2022-09-13
• First posted: 2022-03-22
• Last updated: 2022-03-22

Locations

1 site across 1 country: China