Cell-free DNA Methylation for Epithelial Ovarian Cancer

Phase 2

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

• Registration Number: NCT04651946
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-26
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Last Update Submitted: 2020-11-26
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03
• Primary Completion: 2022-11-26
• Study Completion: 2022-11-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cut-off values of targeted DNA methylation in epithelial ovarian cancer	Two years	The cut-off values are achieve by paired epithelial ovarian cancer and benign ovarian tumor patients.

Secondary Outcome Measures

Name	Time	Method
Accuracy of serum DNA methylation in epithelial ovarian cancer	Two years	The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value.

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China