Circulating Free DNANCT04220710
cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis
An observational study of Circulating Free DNA, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Methylation detection of circulating free DNA to identify markers for diagnosis and differential diagnosis of ovarian endometriosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Circulating Free DNA
- What is being tested?
- DNA extraction and methylation detection
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2019to 20 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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 ;
Who may be able to join
- pathologically diagnosed as ovarian endometriosis;
- surgery was performed in PUMCH
- pathologically diagnosed as epithelial ovarian cancer;
- surgery was performed in PUMCH
- pathologically diagnosed as benign ovarian tumors but not ovarian endometriosis;
- surgery was performed in PUMCH
- ovarian cysts found through ultrasound ;
- surgery will be performed in PUMCH
Who cannot join
- 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:
- 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:
- 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
Show all 11Show fewer
- 2. Marker validation group:
- combined with other gynecological benign and malignant tumors;
- clinically suspected malignant tumors;
- combined with other systemic malignancies or malignancies history;
- pregnant patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Hui Xu, +86-010-69156874, pumchkyc@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Circulating Free DNA
- Being tested
- DNA extraction and methylation detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA extraction and methylation detectionDiagnostic test
DNA extraction and methylation detection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: DNA extraction and methylation detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start20 Aug 2019
- Primary completion20 Feb 2020 (estimated)
- Study completion20 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Free DNAStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shuwang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220710
- Sponsor's protocol ID
- MCFD
- Status last verified
- Jan 2020
- First submitted
- 4 Jan 2020
- Last updated
- 7 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation of cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis
- ClinicalTrials.gov ID
- NCT04220710
- Acronym / sponsor ID
- MCFD
- Conditions
- Circulating Free DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 20 Feb 2020 (estimated)
- Study completion
- 20 Aug 2020 (estimated)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marker selection group | – | Diagnostic Test: DNA extraction and methylation detectionMethalation 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. |
| Marker validation group | – | Diagnostic Test: DNA extraction and methylation detectionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 ;
Key inclusion criteria (8 listed)
- pathologically diagnosed as epithelial ovarian cancer;
- surgery was performed in PUMCH
- pathologically diagnosed as benign ovarian tumors but not ovarian endometriosis;
- surgery was performed in PUMCH
- ovarian cysts found through ultrasound ;
Key exclusion criteria (11 listed)
- patients with ovarian cancer:
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA extraction and methylation detectionDNA extraction and methylation detection | Diagnostic test | Marker selection group, Marker validation group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
Related trials for Circulating Free DNA
Enrolling by invitationObservational study
Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
Cervical Cancer Screening
Active, not recruiting
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Lung Cancer, Lung; Node
RecruitingPhase 1
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingObservational study
Prospective Multicenter Cohort Study of Clinical and Molecular Biomarkers in Colorectal Cancer
Colorectal Neoplasms
Not yet recruiting
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Colorectal Cancer (CRC) Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulating Free DNA, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu Wang (+86-15901276187, 18769781275@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of cfDNA methylation in the diagnosis of ovarian endometriosis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.