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DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

NCT05290428 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 459

Last updated 2022-03-22

No results posted yet for this study

Summary

Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.

Conditions

  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia
  • DNA Methylation
  • Cancer Screening
  • Detection Accuracy

Interventions

DIAGNOSTIC_TEST

DNA methylation testing

All cervical cytology samples will be tested for PAX1 and JAM3 methylation

Sponsors & Collaborators

  • Zhejiang Provincial People's Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • Peking Union Medical College Hospital

    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
2022-03-12
Primary Completion
2022-09-12
Completion
2022-12-12

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 NCT05290428 on ClinicalTrials.gov