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NCT05290415 Clinical Trial

Host DNA Methylation for Endometrial Cancer Screening

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05290415
Other study ID # EC-METHY2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 13, 2022
Est. completion date September 13, 2022

Study information
Verified date March 2022
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 10-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date September 13, 2022
Est. primary completion date June 13, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DNA methylation testing
DNA CDO1 and CELF4 methylation testing

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (2)
Lead Sponsor Collaborator
Lei Li Beijing Qiyuanjuhe Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of methylation testing Sensitivity of methylation testing of cervical cytology compared with histology One week
Primary Specificity of methylation testing Specificity of methylation testing of cervical cytology compared with histology One week
Secondary Positive predictive value of methylation testing Positive predictive value of methylation testing of cervical cytology compared with histology One week
Secondary Negative predictive value of methylation testing Negative predictive value of methylation testing of cervical cytology compared with histology One week
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