DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening

Lei Li

Status: Unknown

Conditions: DNA Methylation; Endometrial Cancer; Cervical Cytology; Cancer Screening; Testing Accuracy

Treatments: Diagnostic Test: DNA methylation testing

Study type: Observational

Funder types: Other

Identifiers

NCT05290922

EC-METHY3

Details and patient eligibility

About

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.

Enrollment: 7,150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With uerine and uterine cervix intact
• Aged 18 years or older
• With accessible histological results of endometrium
• Signed an approved informed consents
• With accessible cervical cytology before harvesting endometrial histology

Exclusion criteria

• Not meeting all of the inclusion criteria