Back to resultsCell-free DNA Methylation for Epithelial Ovarian Cancer
Primary Purpose
Epithelial Ovarian Cancer, DNA Methylation, Benign Ovarian Tumor
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
DNA methylation testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Epithelial Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- With definite histological diagnosis of epithelial ovarian cancer and paired benign ovarian tumor in training set, and with definite histological diagnosis of ovarian tumor in validation set.
- With sufficient fresh peripheral serum and ovarian samples for DNA methylation testing before with or without after major surgeries.
- Aged 18 years or older.
- Signed an approved informed consents
Exclusion Criteria:
- Not meeting all of the inclusion criteria.
Sites / Locations
- Lei LiRecruiting
Outcomes
Primary Outcome Measures
Cut-off values of targeted DNA methylation in epithelial ovarian cancer
The cut-off values are achieve by paired epithelial ovarian cancer and benign ovarian tumor patients.
Secondary Outcome Measures
Accuracy of serum DNA methylation in epithelial ovarian cancer
The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04651946
Brief Title
Cell-free DNA Methylation for Epithelial Ovarian Cancer
Official Title
Cell-free DNA Methylation for the Diagnosis and Monitoring of Epithelial Ovarian Cancer: The Training and Validation Sets in China
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
November 26, 2022 (Anticipated)
Study Completion Date
November 26, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (EOC). In this study, we performed the methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in EOC patients. The study compromises two stages.
In the training set, DNA methylation testing is performed in the ovarian tissues from EOC and paired benign ovarian tumor patients. The cut-off values of methylation are produced in this stage. On the meantime, serum DNA methylation testing is also performed to reveal its accordance and accuracy compared with the results of ovarian tissues.
In the validation set, serum DNA methylation testing is performed in unselected ovarian tumor patients with definite cut-off values to validate its accuracy based on known histology of ovarian tumors.
In training and validation sets, serum DNA methylation is also performed after major surgeries for EOC as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, DNA Methylation, Benign Ovarian Tumor, Training Set, Validation Set, Cell-free DNA, Liquid Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
All eligible patients accept DNA methylation testing in serum and in ovarian tissues.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
DNA methylation testing
Intervention Description
Methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum
Primary Outcome Measure Information:
Title
Cut-off values of targeted DNA methylation in epithelial ovarian cancer
Description
The cut-off values are achieve by paired epithelial ovarian cancer and benign ovarian tumor patients.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Accuracy of serum DNA methylation in epithelial ovarian cancer
Description
The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value.
Time Frame
Two years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
With definite histological diagnosis of epithelial ovarian cancer and paired benign ovarian tumor in training set, and with definite histological diagnosis of ovarian tumor in validation set.
With sufficient fresh peripheral serum and ovarian samples for DNA methylation testing before with or without after major surgeries.
Aged 18 years or older.
Signed an approved informed consents
Exclusion Criteria:
Not meeting all of the inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, M.D.
Phone
+8613911988831
Email
lileigh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Wu, M.D.
Phone
+8613801224549
Email
wuming@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Li, MD
Phone
8613911988831
Email
lileigh@163.com
12. IPD Sharing Statement
Learn more about this trial
Cell-free DNA Methylation for Epithelial Ovarian Cancer
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