DNA Methylation for Screening Uterine Cervical Lesions: A Case-control Study
NCT ID: NCT03961191
Last Updated: 2019-05-23
Study Results
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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UNKNOWN
300 participants
OBSERVATIONAL
2019-05-22
2020-05-22
Brief Summary
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This study will include 300 patients with definite histological results, with 100 of cervical inflammation or low grade squamous intraepithelial lesions (LSIL), 100 of high grade squamous intraepithelial lesions (HSIL), and 100 of uterine cervical cancer. 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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Benign group
Patients with benign cervical histology, including normal findings, inflammation and LSIL
DNA methylation
DNA methylation for the cervical cytology
high-risk HPV
High-risk HPV testing for the cervical cytology
TCT
Thin prep liquid-based cytology test for the cervical cytology
HSIL group
Patients with cervical histology of HSIL
DNA methylation
DNA methylation for the cervical cytology
high-risk HPV
High-risk HPV testing for the cervical cytology
TCT
Thin prep liquid-based cytology test for the cervical cytology
Cancer group
Patients with cervical histology of cancer
DNA methylation
DNA methylation for the cervical cytology
high-risk HPV
High-risk HPV testing for the cervical cytology
TCT
Thin prep liquid-based cytology test for the cervical cytology
Interventions
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DNA methylation
DNA methylation for the cervical cytology
high-risk HPV
High-risk HPV testing for the cervical cytology
TCT
Thin prep liquid-based cytology test for the cervical cytology
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or older
* Signed an approved informed consents
18 Years
FEMALE
No
Sponsors
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Lei Li
OTHER
Responsible Party
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Lei Li
Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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METHY1
Identifier Type: -
Identifier Source: org_study_id
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