DNA Methylation Testing for the Screening of Uterine Cervical Lesion

Phase 3

• Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer; DNA Methylation; High-risk Human Papillomavirus; Cytology
• Interventions: Diagnostic Test: Host DNA methylation testing; Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays

• Registration Number: NCT04646954
• Lead Sponsor: Lei Li

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study Start: 2020-11-26
• Study First Posted: 2020-11-30
• Last Update Posted: 2020-11-30
• Primary Completion: 2022-11-26
• Study Completion: 2022-11-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 12000

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Cervical cytology and/or high-risk human papillomavirus assays	All eligible participants are included in the study group
Study group	Host DNA methylation testing	All eligible participants are included in the study group

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	Two years	The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China