Cervical Cytology, Diagnostic Accuracy, DNA Methylation, Endometrial Cancer, Liquid Biopsy, Training Set, Validation Set
Conditions
Brief summary
Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages. In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues. In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy. In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.
Interventions
DIAGNOSTIC_TESTDNA methylation testing
Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177
Sponsors
Lei Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All eligible patients accept DNA methylation testing in serum, cervical cytology and endometrial tissues.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* With definite histological diagnosis of endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set. * With sufficient fresh peripheral serum, cervical cytology, and endometrial samples for DNA methylation testing before with or without after major surgeries. * Aged 18 years or older. * Signed an approved informed consents
Exclusion criteria
* Not meeting all of the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cut-off values of targeted DNA methylation in endometrial cancer | Two years | The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of serum DNA methylation in endometrial cancer | Two years | The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Backup ContactMing Wu, M.D.
Outcome results
None listed