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DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening

Sponsor
Lei Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT05290922
Collaborator
Obstetrics & Gynecology Hospital of Fudan University (Other), The Third Xiangya Hospital of Central South University (Other), Women's Hospital School Of Medicine Zhejiang University (Other)
7,150
Enrollment
1
Location
12
Anticipated Duration (Months)
596.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: DNA methylation testing

Study Design

Study Type:
Observational
Anticipated Enrollment :
7150 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials
Actual Study Start Date :
Mar 12, 2022
Anticipated Primary Completion Date :
Sep 12, 2022
Anticipated Study Completion Date :
Mar 12, 2023

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of methylation testing [One week]

    Sensitivity of methylation testing of cervical cytology compared with histology

  2. Specificity of methylation testing [One week]

    Specificity of methylation testing of cervical cytology compared with histology

Secondary Outcome Measures

  1. Positive predictive value of methylation testing [One week]

    Positive predictive value of methylation testing of cervical cytology compared with histology

  2. Negative predictive value of methylation testing [One week]

    Negative predictive value of methylation testing of cervical cytology compared with histology

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Inclusion Criteria:

  • With uerine 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Lei Li
  • Obstetrics & Gynecology Hospital of Fudan University
  • The Third Xiangya Hospital of Central South University
  • Women's Hospital School Of Medicine Zhejiang University

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:
NCT05290922
Other Study ID Numbers:
  • EC-METHY3
First Posted:
Mar 22, 2022
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Endometrial Neoplasms

Study Results

No Results Posted as of Mar 22, 2022