Cell-free DNA Methylation for Endometrial Cancer

Lei Li

Status: Unknown

Conditions: Diagnostic Accuracy; DNA Methylation; Endometrial Cancer; Cervical Cytology; Training Set; Validation Set; Liquid Biopsy

Treatments: Diagnostic Test: DNA methylation testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04651738

EC-METHY

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With definite histological diagnosis of endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set.
• With sufficient fresh peripheral serum, cervical cytology, and endometrial 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Study group

Experimental group

Description:

All eligible participants consenting to participate the study.

Treatment:

Diagnostic Test: DNA methylation testing