Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

Study Overview
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Brief Summary
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Epithelial ovarian cancer constitutes one of the most common gynecological malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA.This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.

Detailed Description
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Epithelial ovarian cancer constitutes one of the most common gynecological malignancies, with an incidence rate of 3-12/100 000 woman per year. Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage. Liquid biopsy, which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation. ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ctDNA originates from tumor tissue. This, and the fact that ctDNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer. This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.

Official Title
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Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Diagnostic Test: methylation markers screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people aged 18years to 80years; Diagnosis of ovarian cancer is confirmed by two Pathologists independently; Pregnancy tests are negative. Exclusion Criteria: With other type of malignancies; someone who refuse to participate the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epithelial ovarian cancer<br>patients receive the ctDNA methylation markers screening | Diagnostic Test: methylation markers screening<br>* ctDNA extraction from plasma samples;bisulfite-treated DNA;DNA methylation levels by deep sequencing-Sequencing; data analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological diagnosis of ovarian lumps | Pathological diagnosis of ovarian lumps，including immunohistochemical information and HE staining information. | One week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity (true positive rate) | The proportion of persons with disease who have a positive test (positive test results among persons with disease) | 2 year | 
| Specificity (true negative rate) | The proportion of persons without disease who have a negative test (negative test results among persons without disease) | 2 year |