Cancer Screening, Cervical Cytology, Cohort Study, DNA Methylation, Endometrial Cancer, Liquid Biopsy
Conditions
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.
Interventions
DIAGNOSTIC_TESTDNA methylation testing
DNA CDO1 and CELF4 methylation testing
Sponsors
Beijing Qiyuanjuhe Biotechnology Co., Ltd
Lei Li
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Outcome results
None listed