cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

Circulating Free DNA Clinical Trial

Official title:

Methylation of cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04220710
• Other study ID #: MCFD
• Status: Recruiting
• Start date: August 20, 2019
• Est. completion date: August 20, 2020

Study information

• Verified date: January 2020
• Source: Peking Union Medical College Hospital
• Contact: Shu Wang
• Phone: +86-15901276187
• Email: 18769781275[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Circulating Free DNA
• Endometriosis

Intervention

Diagnostic Test:
• DNA extraction and methylation detection
DNA extraction and methylation detection

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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