MedTrace Logo

Cell-free DNA Methylation for Epithelial Ovarian Cancer

NCT04651946 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-12-03

No results posted yet for this study

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

DIAGNOSTIC_TEST

DNA methylation testing

Methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Principal Investigators

  • Lei Li, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2022-11-26
Completion
2022-11-26

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04651946 on ClinicalTrials.gov