DNA Methylation for Screening Uterine Cervical Lesions
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Sensitivity of DNA methylation [1 year]
Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL)
- Specificity of DNA methylation [1 year]
Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Lei Li | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Lei Li
Investigators
- Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- METHY2