Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04651946
Status:
UNKNOWN
Last Update Posted:
2020-12-03
First Post:
2020-11-26
Brief Title:
Cell-free DNA Methylation for Epithelial Ovarian Cancer
Sponsor:
Lei Li
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Cell-free DNA Methylation for the Diagnosis and Monitoring of Epithelial Ovarian Cancer The Training and Validation Sets in China
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None