Cell-free DNA Methylation for Epithelial Ovarian Cancer
NCT ID: NCT04651946
Last Updated: 2020-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
400 participants
INTERVENTIONAL
2020-11-26
2022-11-26
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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DNA methylation testing
Methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Lei Li
OTHER
Responsible Party
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Lei Li
Professor
Principal Investigators
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Lei Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Lei Li
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Lei Li, MD
Role: primary
Other Identifiers
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EOC-METHY
Identifier Type: -
Identifier Source: org_study_id