DNA Methylation for Screening Uterine Cervical Lesions
DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort Study
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMay 24, 2019
May 1, 2019
1 year
May 21, 2019
May 22, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity of DNA methylation
Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL)
1 year
Specificity of DNA methylation
Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
1 year
Secondary Outcomes (3)
Positive predictive value of DNA methylation
1 year
Negative predictive value of DNA methylation
1 year
Correlation coefficient of DNA methylation with other screening methods
1 year
Interventions
DNA methylation for the cervical cytology
High-risk HPV testing for the cervical cytology
Thin prep liquid-based cytology test for the cervical cytology
Eligibility Criteria
* Confirmed cervical histology within one month when collecting cervical cytology * Aged 18 years or older
You may qualify if:
- Confirmed cervical histology within one month when collecting cervical cytology
- Aged 18 years or older
- Signed an approved informed consents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lei Lilead
Study Sites (1)
Lei Li
Beijing, Beijing Municipality, 100730, China
Biospecimen
Uterine cervical cytology collected during the clinical settings for the testing of DNA methylation, TCT and high-risk HPV
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Li, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 21, 2019
First Posted
May 23, 2019
Study Start
June 1, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
May 24, 2019
Record last verified: 2019-05