Host DNA Methylation for Endometrial Cancer Screening

Sponsor
Lei Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT05290415
Collaborator
Beijing Qiyuanjuhe Biotechnology Co., Ltd (Other)
10,000
1
6
1654.2

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 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.

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 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 Cohort Study
Actual Study Start Date :
Mar 13, 2022
Anticipated Primary Completion Date :
Jun 13, 2022
Anticipated Study Completion Date :
Sep 13, 2022

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
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Lei Li
  • Beijing Qiyuanjuhe Biotechnology Co., Ltd

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:
NCT05290415
Other Study ID Numbers:
  • EC-METHY2
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:

Study Results

No Results Posted as of Mar 22, 2022