cfDNA in Diagnosis and Differential Diagnosis of Ovarian... | NCT04220710

Studies
cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

NCT04220710

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Jan 7, 2020Actual

Enrollment

390Estimated

Phase

Not provided

Conditions

Circulating Free DNA

Interventions

DNA extraction and methylation detection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2019Actual

Primary Completion Date

Feb 20, 2020Estimated

Completion Date

Aug 20, 2020Estimated

First Submitted Date

Jan 4, 2020

First Submission Date that Met QC Criteria

Jan 4, 2020

First Posted Date

Jan 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2020

Last Update Posted Date

Jan 7, 2020Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

390Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA extraction and methylation detection	Diagnostic Test	DNA extraction and methylation detection	Marker selection group Marker validation group

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

1. Marker selection group:

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
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:

pathologically diagnosed as benign ovarian tumors but not 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

2. Marker validation group:

Inclusion Criteria:

ovarian cysts found through ultrasound ;
surgery will be performed in PUMCH

Exclusion Criteria:

combined with other gynecological benign and malignant tumors;
clinically suspected malignant tumors;
combined with other systemic malignancies or malignancies history;
pregnant patients

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample