Back to resultsCell-free DNA Methylation for Endometrial Cancer
Primary Purpose
Endometrial Cancer, Liquid Biopsy, DNA Methylation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DNA methylation testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometrial Cancer
Eligibility Criteria
Inclusion Criteria:
- With definite histological diagnosis of endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set.
- With sufficient fresh peripheral serum, cervical cytology, and endometrial 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
All eligible participants consenting to participate the study.
Outcomes
Primary Outcome Measures
Cut-off values of targeted DNA methylation in endometrial cancer
The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients
Secondary Outcome Measures
Accuracy of serum DNA methylation in endometrial cancer
The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04651738
Brief Title
Cell-free DNA Methylation for Endometrial Cancer
Official Title
Cell-free DNA Methylation for the Diagnosis and Monitoring of Endometrial Cancer: The Training and Validation Sets in China
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (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 endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages.
In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues.
In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy.
In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer 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
Endometrial Cancer, Liquid Biopsy, DNA Methylation, Cervical Cytology, Diagnostic Accuracy, Training Set, Validation Set
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All eligible patients accept DNA methylation testing in serum, cervical cytology and endometrial tissues.
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
All eligible participants consenting to participate the study.
Intervention Type
Diagnostic Test
Intervention Name(s)
DNA methylation testing
Intervention Description
Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177
Primary Outcome Measure Information:
Title
Cut-off values of targeted DNA methylation in endometrial cancer
Description
The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Accuracy of serum DNA methylation in endometrial 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 endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set.
With sufficient fresh peripheral serum, cervical cytology, and endometrial 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 Endometrial Cancer
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