DNA Methylation, High Grade Squamous Intraepithelial Lesions, Low Grade Squamous Intraepithelial Lesions, Uterine Cervical Cancer
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTDNA methylation
DNA methylation for the cervical cytology
DIAGNOSTIC_TESThigh-risk HPV
High-risk HPV testing for the cervical cytology
DIAGNOSTIC_TESTTCT
Thin prep liquid-based cytology test for the cervical cytology
Sponsors
Lei Li
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 any of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of DNA methylation | 1 years | Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL |
| Specificity of DNA methylation | 1 years | Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value of DNA methylation | 1 year | Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL |
| Negative predictive value of DNA methylation | 1 year | Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL |
| Correlation coefficient of DNA methylation with other screening methods | 1 year | Correlation coefficient of DNA methylation with high-risk HPV and TCT results |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Outcome results
None listed