NCT04651738

Cell-free DNA Methylation for Endometrial Cancer

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

• Status: Unknown
• Phase: N/A
• 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 endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages. In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues. In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy. In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.

Conditions

• Endometrial Cancer
• Liquid Biopsy
• DNA Methylation
• Cervical Cytology
• Diagnostic Accuracy
• Training Set
• Validation Set

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DNA methylation testing	Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177

Timeline

• Start date: 2020-12-18
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2020-12-03
• Last updated: 2020-12-21

Locations

1 site across 1 country: China