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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA methylation | Diagnostic Test | DNA methylation for the cervical cytology | ||
| High-risk HPV | Diagnostic Test | High-risk HPV testing for the cervical cytology | ||
| TCT | Diagnostic Test | Thin prep liquid-based cytology test for the cervical cytology |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of DNA methylation | Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL) | 1 year |
| Specificity of DNA methylation | Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Positive predictive value of DNA methylation | Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL | 1 year |
| Negative predictive value of DNA methylation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li | Contact | +8613911988831 | lilei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D000081483 | Squamous Intraepithelial Lesions |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019175 | DNA Methylation |
| ID | Term |
|---|---|
| D008745 | Methylation |
| D000478 | Alkylation |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
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Uterine cervical cytology collected during the clinical settings for the testing of DNA methylation, TCT and high-risk HPV
Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
| 1 year |
| Correlation coefficient of DNA methylation with other screening methods | Correlation coefficient of DNA methylation with high-risk HPV and TCT results | 1 year |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008660 |
| Metabolism |
| D055614 | Genetic Phenomena |