Cell-free DNA Methylation for Endometrial Cancer

December 17, 2020 updated by: Lei Li

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cut-off values of targeted DNA methylation in endometrial cancer
Time Frame: Two years
The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of serum DNA methylation in endometrial cancer
Time Frame: Two years
The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lei Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 18, 2020

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (ACTUAL)

December 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-METHY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometrial Cancer

Clinical Trials on DNA methylation testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe