Cell-free DNA Methylation for Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651738
• Other study ID #: EC-METHY
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: December 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• DNA methylation testing
Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177

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 endometrial cancer	The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients	Two years
Secondary	Accuracy of serum DNA methylation in endometrial cancer	The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value	Two years