Host DNA Methylation for Endometrial Cancer Screening

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

• Registration Number: NCT05290415
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-12
• Study First Submitted QC: 2022-03-12
• Last Update Submitted: 2022-03-12
• Study Start: 2022-03-13
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22
• Primary Completion: 2022-06-13
• Study Completion: 2022-09-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of methylation testing	One week	Sensitivity of methylation testing of cervical cytology compared with histology
Specificity of methylation testing	One week	Specificity of methylation testing of cervical cytology compared with histology

Secondary Outcome Measures

Name	Time	Method
Positive predictive value of methylation testing	One week	Positive predictive value of methylation testing of cervical cytology compared with histology
Negative predictive value of methylation testing	One week	Negative predictive value of methylation testing of cervical cytology compared with histology

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China