cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

• Conditions: Circulating Free DNA
• Interventions: Diagnostic Test: DNA extraction and methylation detection

• Registration Number: NCT04220710
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-08-20
• Status Verified: 2020-01
• Study First Submitted: 2020-01-04
• Study First Submitted QC: 2020-01-04
• Last Update Submitted: 2020-01-04
• Study First Posted: 2020-01-07
• Last Update Posted: 2020-01-07
• Primary Completion: 2020-02-20
• Study Completion: 2020-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 390

Inclusion Criteria

1. pathologically diagnosed as ovarian endometriosis; 2. 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. patients with ovarian cancer:

Inclusion Criteria:

1. pathologically diagnosed as epithelial ovarian cancer;
2. surgery was performed in PUMCH

Exclusion Criteria:

1. combined with gynecological benign tumors and other malignant tumors;
2. combined with other systemic malignancies or malignancies history;
3. pregnant patients (3) patients with other benign ovarian tumors:

Inclusion Criteria:

1. pathologically diagnosed as benign ovarian tumors but not ovarian endometriosis;
2. 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:

1. ovarian cysts found through ultrasound ;
2. surgery will be performed in PUMCH

Exclusion Criteria:

1. combined with other gynecological benign and malignant tumors;
2. clinically suspected malignant tumors;
3. combined with other systemic malignancies or malignancies history;
4. pregnant patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Marker selection group	DNA extraction and methylation detection	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.
Marker validation group	DNA extraction and methylation detection	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.

Primary Outcome Measures

Name	Time	Method
The efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis	12 months	The sensitivity, specificity and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China