cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

Study Overview
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Brief Summary
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Methylation detection of circulating free DNA to identify markers for diagnosis and differential diagnosis of ovarian endometriosis.

Detailed Description
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Methylation detection of circulating free DNA and FFPF samples from patients with ovarian endometriosis, ovarian cancer and other benign ovarian cysts will be performed to select markers for ovarian endometriosis diagnosis. The markers will be validated in patients with ovarian cysts found by ultrasound. The diagnosis accuracy of the markers will be evaluated by comparing with the pathological diagnosis.

Official Title
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Methylation of cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

Conditions
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Circulating Free DNA

Intervention / Treatment
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* Diagnostic Test: DNA extraction and methylation detection


Participation Criteria
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Eligibility Criteria
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1. Marker selection group: patients with ovarian endometriosis: Inclusion Criteria: pathologically diagnosed as ovarian endometriosis; surgery was performed in PUMCH Exclusion Criteria: a. combined with other gynecological benign and malignant tumors; b. clinically suspected malignant tumors; c. combined with other systemic malignancies or malignancies history; d. pregnant patients patients with ovarian cancer: Inclusion Criteria: pathologically diagnosed as epithelial ovarian cancer; surgery was performed in PUMCH Exclusion Criteria: combined with gynecological benign tumors and other malignant tumors; combined with other systemic malignancies or malignancies history; pregnant patients (3) patients with other benign ovarian tumors: Inclusion Criteria: pathologically diagnosed as benign ovarian tumors but not ovarian endometriosis; surgery was performed in PUMCH Exclusion Criteria: a. combined with other gynecological benign and malignant tumors; b. clinically suspected malignant tumors; c. combined with other systemic malignancies or malignancies history; d. pregnant patients 2. Marker validation group: Inclusion Criteria: ovarian cysts found through ultrasound ; surgery will be performed in PUMCH Exclusion Criteria: combined with other gynecological benign and malignant tumors; clinically suspected malignant tumors; combined with other systemic malignancies or malignancies history; pregnant patients

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Marker selection group<br>Methalation detection of circulating free DNA and FFPF samples from pathologically confirmed patients with ovarian endometriosis(30 cases), ovarian cancer (30 cases)and other benign ovarian tumors (30 cases)will be performed to select markers for ovarian endometriosis diagnosis. | Diagnostic Test: DNA extraction and methylation detection<br>* DNA extraction and methylation detection<br>|
| Marker validation group<br>The selected markers will be validated in patients with ovarian cysts (300 cases )found by ultrasound. The diagnosis accuracy of the markers will be evaluated by comparing with the pathological diagnosis. | Diagnostic Test: DNA extraction and methylation detection<br>* DNA extraction and methylation detection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis | The sensitivity, specificity and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis | 12 months |