cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

January 4, 2020 updated by: shuwang, Peking Union Medical College Hospital

Methylation of cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

  1. Marker selection group: patients with ovarian endometriosis, ovarian cancer and other benign ovarian tumors
  2. Marker validation group: patients with ovarian cysts found through ultrasound ;

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: DNA extraction and methylation detection
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.
Diagnostic test: DNA extraction and methylation detection
DNA extraction and methylation detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2019

Primary Completion (ANTICIPATED)

February 20, 2020

Study Completion (ANTICIPATED)

August 20, 2020

Study Registration Dates

First Submitted

January 4, 2020

First Submitted That Met QC Criteria

January 4, 2020

First Posted (ACTUAL)

January 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 4, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCFD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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