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Clinical Trials/NCT04220710
NCT04220710
Unknown
Not Applicable

Methylation of cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

Peking Union Medical College Hospital1 site in 1 country390 target enrollmentAugust 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Circulating Free DNA
Sponsor
Peking Union Medical College Hospital
Enrollment
390
Locations
1
Primary Endpoint
The efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2019
End Date
August 20, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

shuwang

Associate Professor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

  • pathologically diagnosed as ovarian endometriosis;
  • 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
  • patients with ovarian cancer:
  • Inclusion Criteria:
  • pathologically diagnosed as epithelial ovarian cancer;
  • surgery was performed in PUMCH
  • Exclusion Criteria:
  • combined with gynecological benign tumors and other malignant tumors;
  • combined with other systemic malignancies or malignancies history;
  • pregnant patients (3) patients with other benign ovarian tumors:
  • Inclusion Criteria:

Outcomes

Primary Outcomes

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

Study Sites (1)

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