Circulating Free DNA Clinical Trial
Official title:
Methylation of cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis
NCT number | NCT04220710 |
Other study ID # | MCFD |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 20, 2019 |
Est. completion date | August 20, 2020 |
Methylation detection of circulating free DNA to identify markers for diagnosis and differential diagnosis of ovarian endometriosis.
Status | Recruiting |
Enrollment | 390 |
Est. completion date | August 20, 2020 |
Est. primary completion date | February 20, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
1. Marker selection group: 1. 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 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 |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |