Cell-free DNA Methylation for Epithelial Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651946
• Other study ID #: EOC-METHY
• Status: Recruiting
• Phase: Phase 2
• Start date: November 26, 2020
• Est. completion date: November 26, 2022

Study information

• Verified date: November 2020
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: +8613911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 26, 2022
• Est. primary completion date: November 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• DNA methylation testing
Methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cut-off values of targeted DNA methylation in epithelial ovarian cancer	The cut-off values are achieve by paired epithelial ovarian cancer and benign ovarian tumor patients.	Two years
Secondary	Accuracy of serum DNA methylation in epithelial ovarian cancer	The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value.	Two years