DNA Methylation for Screening Uterine Cervical Lesions

NCT ID: NCT03960879

Last Updated: 2019-05-24

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-06-01

Brief Summary

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The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study.

This study will include 300 unselected patients with definite histological results. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.

The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.

Detailed Description

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Conditions

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DNA Methylation Uterine Cervical Cancer High Grade Squamous Intraepithelial Lesions Low Grade Squamous Intraepithelial Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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DNA methylation

DNA methylation for the cervical cytology

Intervention Type DIAGNOSTIC_TEST

High-risk HPV

High-risk HPV testing for the cervical cytology

Intervention Type DIAGNOSTIC_TEST

TCT

Thin prep liquid-based cytology test for the cervical cytology

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Confirmed cervical histology within one month when collecting cervical cytology
* 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

Role: CONTACT

+8613911988831

Facility Contacts

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Lei Li, MD

Role: primary

008613911988831

Other Identifiers

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METHY2

Identifier Type: -

Identifier Source: org_study_id

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