Cell-free DNA Methylation for Endometrial Cancer

NCT ID: NCT04651738

Last Updated: 2020-12-21

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

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2023-01-01

Brief Summary

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Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages.

In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues.

In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy.

In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.

Detailed Description

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Conditions

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Endometrial Cancer Liquid Biopsy DNA Methylation Cervical Cytology Diagnostic Accuracy Training Set Validation Set

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All eligible patients accept DNA methylation testing in serum, cervical cytology and endometrial tissues.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study group

All eligible participants consenting to participate the study.

Group Type EXPERIMENTAL

DNA methylation testing

Intervention Type DIAGNOSTIC_TEST

Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177

Interventions

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DNA methylation testing

Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* With definite histological diagnosis of endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set.
* With sufficient fresh peripheral serum, cervical cytology, and endometrial samples for DNA methylation testing before with or without after major surgeries.
* Aged 18 years or older.
* Signed an approved informed consents
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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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

Phone: +8613911988831

Email: [email protected]

Ming Wu, M.D.

Role: CONTACT

Phone: +8613801224549

Email: [email protected]

Facility Contacts

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Lei Li, MD

Role: primary

Other Identifiers

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EC-METHY

Identifier Type: -

Identifier Source: org_study_id