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
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.
Study Type
Interventional
Primary Outcome
Cut-off values of targeted DNA methylation in endometrial cancer
Secondary Outcome
Accuracy of serum DNA methylation in endometrial cancer
Condition
Endometrial Cancer
Intervention
DNA methylation testing
Study Arms / Comparison Groups
Study group
Description: All eligible participants consenting to participate the study.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
400
Start Date
December 18, 2020
Completion Date
January 1, 2023
Primary Completion Date
January 1, 2023
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lei Li, M.D., +8613911988831, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04651738
Organization ID
EC-METHY
Responsible Party
Sponsor-Investigator
Study Sponsor
Lei Li
Study Sponsor
Lei Li, M.D., Principal Investigator, Peking Union Medical College Hospital
Verification Date
December 2020