Host DNA Methylation for Endometrial Cancer Screening
Study Details
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 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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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With uterine and uterine cervix intact
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Aged 18 years or older
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With accessible histological results of endometrium
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Signed an approved informed consents
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With accessible cervical cytology before harvesting endometrial histology
Exclusion Criteria:
- Not meeting all of the inclusion criteria
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Lei Li | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Lei Li
- Beijing Qiyuanjuhe Biotechnology Co., Ltd
Investigators
- Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EC-METHY2