DNA CDO1 and CELF4 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, Double-blind, Parallel Controlled Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05290922
• Other study ID #: EC-METHY3
• Status: Recruiting
• Start date: March 12, 2022
• Est. completion date: March 12, 2023

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
• 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7150
• Est. completion date: March 12, 2023
• Est. primary completion date: September 12, 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Screening
• Cervical Cytology
• DNA Methylation
• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Diagnostic Test:
• DNA methylation testing
The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation.

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Lei Li	Obstetrics & Gynecology Hospital of Fudan University, The Third Xiangya Hospital of Central South University, Women's Hospital School Of Medicine Zhejiang University

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