Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Squamous Intraepithelial Lesions of the Cervix

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Cervical Dysplasia

Precancerous Conditions

Cervical Intraepithelial Neoplasia

DNA methylation for the cervical cytology

DNA methylation

High-risk HPV testing for the cervical cytology

High-risk HPV

Thin prep liquid-based cytology test for the cervical cytology

Lei Li

Lei Li, MD

Lei Li, M.D.

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.

Uterine cervical cytology collected during the clinical settings for the testing of DNA methylation, TCT and high-risk HPV

DNA Methylation for Screening Uterine Cervical Lesions

DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort Study

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 compared with histological results for the differentiation of cervical cancer and HSIL

Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

Correlation coefficient of DNA methylation with high-risk HPV and TCT results

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
DNA Methylation for Screening Uterine Cervical Lesions	NCT03960879	DNA Methylation Uterine Cervica... High Grade Squa... Low Grade Squam...	DNA methylation High-risk HPV TCT	18 Years -	Peking Union Medical College Hospital
DNA Methylation for Screening Uterine Cervical Lesions	NCT03960879	DNA Methylation Uterine Cervica... High Grade Squa... Low Grade Squam...	DNA methylation High-risk HPV TCT	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for low grade squamous intraepithelial lesions