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NCT04646954 Clinical Trial

DNA Methylation Testing for the Screening of Uterine Cervical Lesion

Cervical Cancer Clinical Trial

Official title:
DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Multicenter, Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04646954
Other study ID # METHY3
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 26, 2020
Est. completion date November 26, 2022

Study information
Verified date November 2020
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone +8613911988831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 12000
Est. completion date November 26, 2022
Est. primary completion date November 26, 2022
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Host DNA methylation testing
Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample
• Cervical cytology and/or high-risk human papillomavirus assays
Cervical cytology and/or high-risk human papillomavirus assays

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value. Two years
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