MedTrace Logo

DNA Methylation Testing for the Screening of Uterine Cervical Lesion

NCT04646954 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12000

Last updated 2020-11-30

No results posted yet for this study

Summary

In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

Conditions

  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia
  • DNA Methylation
  • High-risk Human Papillomavirus
  • Cytology

Interventions

DIAGNOSTIC_TEST

Host DNA methylation testing

Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample

DIAGNOSTIC_TEST

Cervical cytology and/or high-risk human papillomavirus assays

Cervical cytology and/or high-risk human papillomavirus assays

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2022-11-26
Completion
2022-11-26

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04646954 on ClinicalTrials.gov