DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening

NCT ID: NCT05290922

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

7150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-12

Study Completion Date

2023-03-12

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Cancer Cancer Screening DNA Methylation Testing Accuracy Cervical Cytology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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DNA methylation testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Obstetrics & Gynecology Hospital of Fudan University

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role collaborator

Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D

Role: CONTACT

10-139-1198-8831

Facility Contacts

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Lei Li, MD

Role: primary

8613911988831

Other Identifiers

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EC-METHY3

Identifier Type: -

Identifier Source: org_study_id

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