Host DNA Methylation for Endometrial Cancer Screening

March 12, 2022 updated by: Lei Li

The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center Cohort Study

Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening in a multi-center cohort. Thirteen hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 10,000 patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

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

Study Contact

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

Sampling Method

Non-Probability Sample

Study Population

All participants will accept surgeries harvesting endometrial histology.

Description

Inclusion Criteria:

  • With uterine and uterine cervix intact
  • Aged 18 years or older
  • With accessible histological results of endometrium
  • Signed an approved informed consents
  • With accessible cervical cytology before harvesting endometrial histology

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of methylation testing
Time Frame: One week
Sensitivity of methylation testing of cervical cytology compared with histology
One week
Specificity of methylation testing
Time Frame: One week
Specificity of methylation testing of cervical cytology compared with histology
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value of methylation testing
Time Frame: One week
Positive predictive value of methylation testing of cervical cytology compared with histology
One week
Negative predictive value of methylation testing
Time Frame: One week
Negative predictive value of methylation testing of cervical cytology compared with histology
One week

Collaborators and Investigators

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

Sponsor

Lei Li

Collaborators

Beijing Qiyuanjuhe Biotechnology Co., Ltd

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)

March 13, 2022

Primary Completion (Anticipated)

June 13, 2022

Study Completion (Anticipated)

September 13, 2022

Study Registration Dates

First Submitted

March 12, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-METHY2

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.

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