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DNA Methylation Testing for the Screening of Uterine Cervical Lesion

NCT ID: NCT04646954

Last Updated: 2020-11-30

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

PHASE3

Total Enrollment

12000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-26

Study Completion Date

2022-11-26

Brief Summary

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In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

Detailed Description

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Conditions

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Cervical Cancer Cervical Intraepithelial Neoplasia DNA Methylation High-risk Human Papillomavirus Cytology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study group

All eligible participants are included in the study group

Group Type EXPERIMENTAL

Host DNA methylation testing

Intervention Type DIAGNOSTIC_TEST

Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample

Cervical cytology and/or high-risk human papillomavirus assays

Intervention Type DIAGNOSTIC_TEST

Cervical cytology and/or high-risk human papillomavirus assays

Interventions

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Host DNA methylation testing

Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample

Intervention Type DIAGNOSTIC_TEST

Cervical cytology and/or high-risk human papillomavirus assays

Cervical cytology and/or high-risk human papillomavirus assays

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Aged 21 years or older
* Signed an approved informed consents
* Feasible to be followed up
* Available residual cytology samples for methylation analysis

Exclusion Criteria

* Without history of cervical disease, including cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
* No requirement of cervical cancer screening of cytology or high-risk human papillomavirus
Minimum Eligible Age

21 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]

Facility Contacts

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Lei Li, MD

Role: primary

Other Identifiers

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METHY3

Identifier Type: -

Identifier Source: org_study_id