Cell-free DNA Methylation for Epithelial Ovarian Cancer

Study Overview
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Brief Summary
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Liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (EOC). In this study, we performed the methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in EOC patients. The study compromises two stages. In the training set, DNA methylation testing is performed in the ovarian tissues from EOC and paired benign ovarian tumor patients. The cut-off values of methylation are produced in this stage. On the meantime, serum DNA methylation testing is also performed to reveal its accordance and accuracy compared with the results of ovarian tissues. In the validation set, serum DNA methylation testing is performed in unselected ovarian tumor patients with definite cut-off values to validate its accuracy based on known histology of ovarian tumors. In training and validation sets, serum DNA methylation is also performed after major surgeries for EOC 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 Epithelial Ovarian Cancer: The Training and Validation Sets in China

Conditions
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Epithelial Ovarian Cancer, DNA Methylation, Benign Ovarian Tumor, Training Set, Validation Set, Cell-free DNA, Liquid Biopsy

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 epithelial ovarian cancer and paired benign ovarian tumor in training set, and with definite histological diagnosis of ovarian tumor in validation set. With sufficient fresh peripheral serum and ovarian 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All eligible patients accept DNA methylation testing in serum and in ovarian tissues.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: DNA methylation testing|Methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum|

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 epithelial ovarian cancer | The cut-off values are achieve by paired epithelial ovarian cancer and benign ovarian tumor patients. | Two years | 

Secondary Outcome Measures

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