Cell-free DNA Methylation for Endometrial Cancer

Sponsor

Lei Li (Other)

Overall Status

Recruiting

CT.gov ID

NCT04651738

Collaborator

(none)

400

Enrollment

Location

Arm

24.4

Anticipated Duration (Months)

16.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer Liquid Biopsy DNA Methylation Cervical Cytology Diagnostic Accuracy Training Set Validation Set	Diagnostic Test: DNA methylation testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All eligible patients accept DNA methylation testing in serum, cervical cytology and endometrial tissues.All eligible patients accept DNA methylation testing in serum, cervical cytology and endometrial tissues.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Dec 18, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group All eligible participants consenting to participate the study.	Diagnostic Test: DNA methylation testing Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177

Arm

Intervention/Treatment

Experimental: Study group

All eligible participants consenting to participate the study.

Diagnostic Test: DNA methylation testing

Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177

Outcome Measures

Primary Outcome Measures

Cut-off values of targeted DNA methylation in endometrial cancer [Two years]
The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients

Secondary Outcome Measures

Accuracy of serum DNA methylation in endometrial cancer [Two years]
The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lei Li	Beijing	Beijing	China	100730

Sponsors and Collaborators

Lei Li

Investigators

Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lei Li, Professor, Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT04651738

Other Study ID Numbers:

EC-METHY

First Posted:

Dec 3, 2020

Last Update Posted:

Dec 21, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometrial Neoplasms

Study Results

No Results Posted as of Dec 21, 2020