Cell-free DNA Methylation for Epithelial Ovarian Cancer

  • STATUS
    Recruiting
  • End date
    Nov 26, 2022
  • participants needed
    400
  • sponsor
    Lei Li
Updated on 27 January 2021

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.

Details
Condition DNA Methylation, Ovarian Epithelial Cancer, Epithelial Ovarian Cancer, Epithelial Ovarian Carcinoma, ovarian epithelial carcinoma, carcinoma of the ovary, cfdna, cell-free dna, cell free dna, circulating dna, cell free deoxyribonucleic acid, liquid biopsies, liquid biopsy, Benign Ovarian Tumor, Training Set, Validation Set
Treatment DNA methylation testing
Clinical Study IdentifierNCT04651946
SponsorLei Li
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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