cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

NCT ID: NCT04220710

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-20

Study Completion Date

2020-08-20

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.

Conditions

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Circulating Free DNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Marker selection group

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.

DNA extraction and methylation detection

Intervention Type DIAGNOSTIC_TEST

DNA extraction and methylation detection

Marker validation group

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.

DNA extraction and methylation detection

Intervention Type DIAGNOSTIC_TEST

DNA extraction and methylation detection

Interventions

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DNA extraction and methylation detection

DNA extraction and methylation detection

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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


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


1. pathologically diagnosed as benign ovarian tumors but not ovarian endometriosis;
2. surgery was performed in PUMCH


1. ovarian cysts found through ultrasound ;
2. surgery will be 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:


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:


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:


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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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shuwang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shu Wang

Role: CONTACT

+86-15901276187

Facility Contacts

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Hui Xu

Role: primary

+86-010-69156874

Other Identifiers

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MCFD

Identifier Type: -

Identifier Source: org_study_id

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