Host DNA Methylation for Endometrial Cancer Screening

Lei Li

Status: Unknown

Conditions: DNA Methylation; Endometrial Cancer; Cervical Cytology; Cancer Screening; Cohort Study; Liquid Biopsy

Treatments: Diagnostic Test: DNA methylation testing

Study type: Observational

Funder types: Other

Identifiers

NCT05290415

EC-METHY2

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 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.

Enrollment: 10,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With uterine 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