cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Circulating Free DNA

Treatments: Diagnostic Test: DNA extraction and methylation detection

Study type: Observational

Funder types: Other

Identifiers

NCT04220710

MCFD

Details and patient eligibility

About

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

Full 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.

Enrollment: 390 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Marker selection group:

2. patients with ovarian endometriosis:

   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

3. 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

Trial design

390 participants in 2 patient groups

Marker selection group

Description:

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.

Treatment:

Diagnostic Test: DNA extraction and methylation detection

Marker validation group

Description:

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.

Treatment:

Diagnostic Test: DNA extraction and methylation detection