Back to resultsDNA Methylation Testing for the Screening of Uterine Cervical Lesion
Primary Purpose
Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Host DNA methylation testing
Cervical cytology and/or high-risk human papillomavirus assays
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer
Eligibility Criteria
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
Sites / Locations
- Lei LiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
All eligible participants are included in the study group
Outcomes
Primary Outcome Measures
Diagnostic accuracy
The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04646954
Brief Title
DNA Methylation Testing for the Screening of Uterine Cervical Lesion
Official Title
DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Multicenter, Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
November 26, 2022 (Anticipated)
Study Completion Date
November 26, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation, High-risk Human Papillomavirus, Cytology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
All eligible participants are included in the study group
Intervention Type
Diagnostic Test
Intervention Name(s)
Host DNA methylation testing
Intervention Description
Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample
Intervention Type
Diagnostic Test
Intervention Name(s)
Cervical cytology and/or high-risk human papillomavirus assays
Intervention Description
Cervical cytology and/or high-risk human papillomavirus assays
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Time Frame
Two years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, M.D.
Phone
+8613911988831
Email
lileigh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Li, MD
Phone
8613911988831
Email
lileigh@163.com
12. IPD Sharing Statement
Learn more about this trial
DNA Methylation Testing for the Screening of Uterine Cervical Lesion
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