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DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening

NCT05290922 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 7150

Last updated 2022-03-22

No results posted yet for this study

Summary

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. This study would provide profound basis for the approval of assay kit of DNA methylation in China for endometrial screening. Four 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 7150 patients.

Conditions

Interventions

DIAGNOSTIC_TEST

DNA methylation testing

The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation.

Sponsors & Collaborators

  • Obstetrics & Gynecology Hospital of Fudan University

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • Women's Hospital School Of Medicine Zhejiang University

    collaborator OTHER

  • Lei Li

    lead OTHER

Principal Investigators

  • Lei Li, M.D. · Peking Union Medical College Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-12
Primary Completion
2022-09-12
Completion
2023-03-12

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05290922 on ClinicalTrials.gov