Spots Global Cancer Trial Database for DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening
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Trial Identification
Brief Title: DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening
Official Title: The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials
Study ID: NCT05290922
Interventions
Study Description
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. 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Lei Li, Beijing, Beijing, China
Contact Details
Name: Lei Li, M.D.
Affiliation: Peking Union Medical College Hospital
Role: PRINCIPAL_INVESTIGATOR
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