Trials / Unknown
UnknownNCT03961191
DNA Methylation for Screening Uterine Cervical Lesions: A Case-control Study
Utilization of DNA Methylation in the Screening of Uterine Cervical Lesions: A Case-control Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Lei Li · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 in a case-control study, so as to determine the accuracy of DNA methylation in the screening of uterine cervical lesions. This study will include 300 patients with definite histological results, with 100 of cervical inflammation or low grade squamous intraepithelial lesions (LSIL), 100 of high grade squamous intraepithelial lesions (HSIL), and 100 of uterine cervical cancer. 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
- DNA Methylation
- Uterine Cervical Cancer
- High Grade Squamous Intraepithelial Lesions
- Low Grade Squamous Intraepithelial Lesions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | DNA methylation | DNA methylation for the cervical cytology |
| DIAGNOSTIC_TEST | high-risk HPV | High-risk HPV testing for the cervical cytology |
| DIAGNOSTIC_TEST | TCT | Thin prep liquid-based cytology test for the cervical cytology |
Timeline
- Start date
- 2019-05-22
- Primary completion
- 2020-05-22
- Completion
- 2020-05-22
- First posted
- 2019-05-23
- Last updated
- 2019-05-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03961191. Inclusion in this directory is not an endorsement.