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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Diagnostic accuracy
Condition
Cervical Cancer
Intervention
Host DNA methylation testing
Study Arms / Comparison Groups
Study group
Description: All eligible participants are included in the study group
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
12000
Start Date
November 26, 2020
Completion Date
November 26, 2022
Primary Completion Date
November 26, 2022
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
Gender
Female
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lei Li, M.D., +8613911988831, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04646954
Organization ID
METHY3
Responsible Party
Sponsor-Investigator
Study Sponsor
Lei Li
Study Sponsor
Lei Li, M.D., Principal Investigator, Peking Union Medical College Hospital
Verification Date
November 2020