Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cytology | — | UNRESOLVED | — |
| DNA Methylation | — | UNRESOLVED | — |
| High-risk Human Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical cytology and/or high-risk human papillomavirus assays | Diagnostic Test | — | UNRESOLVED |
| Host DNA methylation testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- All eligible participants are included in the study group
- interventionNames
- Diagnostic Test: Host DNA methylation testing
- Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays
Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- Two years
- description
- The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKong L, Xiao X, Wu H, You Y, Jin X, Liou Y, Liu P, Lang J, Li L. Triage performance of DNA methylation for women with high-risk human papillomavirus infection. Oncologist. 2025 Mar 10;30(3):oyae324. doi: 10.1093/oncolo/oyae324. PMID 39603822