NCT04651946

Cell-free DNA Methylation for Epithelial Ovarian Cancer

Cell-free DNA Methylation for the Diagnosis and Monitoring of Epithelial Ovarian Cancer: The Training and Validation Sets in China

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer
• DNA Methylation
• Benign Ovarian Tumor
• Training Set
• Validation Set
• Cell-free DNA
• Liquid Biopsy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DNA methylation testing	Methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum

Timeline

• Start date: 2020-11-26
• Primary completion: 2022-11-26
• Completion: 2022-11-26
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

1 site across 1 country: China