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DNA Methylation for Screening Uterine Cervical Lesions: A Case-control Study

NCT03961191 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2019-05-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Principal Investigators

  • Lei Li, M.D. · Peking Union Medical College Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2020-05-22
Completion
2020-05-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961191 on ClinicalTrials.gov