Trials / Unknown
UnknownNCT04646954
DNA Methylation Testing for the Screening of Uterine Cervical Lesion
DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Multicenter, Prospective Cohort Study
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 12,000 (estimated)
- Sponsor
- Lei Li · Academic / Other
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cervical Cancer
- Cervical Intraepithelial Neoplasia
- DNA Methylation
- High-risk Human Papillomavirus
- Cytology
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Host DNA methylation testing | Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample |
| DIAGNOSTIC_TEST | Cervical cytology and/or high-risk human papillomavirus assays | Cervical cytology and/or high-risk human papillomavirus assays |
Timeline
- Start date
- 2020-11-26
- Primary completion
- 2022-11-26
- Completion
- 2022-11-26
- First posted
- 2020-11-30
- Last updated
- 2020-11-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04646954. Inclusion in this directory is not an endorsement.