Cell-free DNA Methylation for Endometrial Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Cell-free DNA Methylation for the Diagnosis and Monitoring of Endometrial Cancer: The Training and Validation Sets in China

Conditions
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Endometrial Cancer, Liquid Biopsy, DNA Methylation, Cervical Cytology, Diagnostic Accuracy, Training Set, Validation Set

Intervention / Treatment
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* Diagnostic Test: DNA methylation testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All eligible patients accept DNA methylation testing in serum, cervical cytology and endometrial tissues.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>All eligible participants consenting to participate the study. | Diagnostic Test: DNA methylation testing<br>* Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut-off values of targeted DNA methylation in endometrial cancer | The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of serum DNA methylation in endometrial cancer | The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value | Two years |