Clinical trial · Observational
DNA Methylation for Screening Uterine Cervical Lesions
DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A 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)
The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study. This study will include 300 unselected patients with definite histological results. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed. The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DNA Methylation | — | UNRESOLVED | — |
| High Grade Squamous Intraepithelial Lesions | — | UNRESOLVED | — |
| Low Grade Squamous Intraepithelial Lesions | — | UNRESOLVED | — |
| Uterine Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA methylation | Diagnostic Test | — | UNRESOLVED |
| High-risk HPV | Diagnostic Test | — | UNRESOLVED |
| TCT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Sensitivity of DNA methylation
- timeFrame
- 1 year
- description
- Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL)
- measure
- Specificity of DNA methylation
- timeFrame
- 1 year
- description
- Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Secondary outcomes (3)
- measure
- Positive predictive value of DNA methylation
- timeFrame
- 1 year
- description
- Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed cervical histology within one month when collecting cervical cytology * Aged 18 years or older * Signed an approved informed consents Exclusion Criteria: * Not meeting all of the inclusion criteria
References
Publications (0)
Data not yet available