Cancer Screening, Cervical Cytology, DNA Methylation, Endometrial Cancer, Testing Accuracy
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. 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.
Interventions
DIAGNOSTIC_TESTDNA methylation testing
The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation.
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
The Third Xiangya Hospital of Central South University
Women's Hospital School Of Medicine Zhejiang University
Lei Li
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
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