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Cervical Cytology DNA Methylation for Cervical Cancer Screening

NCT06557954 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30000

Last updated 2024-08-19

No results posted yet for this study

Summary

Cervical cancer represents one of the foremost causes of cancer-related morbidity and mortality among women worldwide. Given the current limitations, such as the low specificity of human papillomavirus (HPV) testing and the relatively low sensitivity of cytological examinations, there is a pressing need for a novel, non-invasive, safe, and precise screening method. This study aims to undertake a multicentre, real-world investigation, incorporating at least 10 sub-centres and enrolling 30,000 participants. Histopathological examination results will serve as the 'gold standard' for evaluating the screening efficacy of human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m), HPV testing, and cytological examinations. Furthermore, the study seeks to elucidate the relationship between DNA methylation levels and persistent HPV infection, while also assessing the applicability of PAX1m/JAM3m across diverse clinical settings. By focusing on alterations in DNA methylation levels within cervical exfoliated cells as the primary research trajectory, this study aspires to furnish novel insights and theoretical foundations for the prevention and management of cervical cancer, targeting PAX1m/JAM3m. The ultimate objective is to facilitate the clinical implementation of an enhanced cervical cancer screening protocol, thereby addressing the deficiencies of current screening methodologies, achieving greater precision in cervical cancer screening, and effectively reducing the incidence of cervical cancer while mitigating the risks of overdiagnosis and overtreatment.

Conditions

  • Cervical Cancer
  • DNA Methylation
  • Cytology
  • Human Papillomavirus Infection
  • Cervical Intraepithelial Neoplasia
  • Cancer Screening

Interventions

DIAGNOSTIC_TEST

human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m)

PAX1m/JAM3m, with or without HPV testing and cytological pathology for cervical cancer screening

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
2024-09-01
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • China

Study Locations

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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 NCT06557954 on ClinicalTrials.gov