About this trial

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.

Eligibility criteria

Qualifiers

Aged 18 years or older

With uterine cervix intact

Given consents to participate the study

With detailed follow-up outcomes

Disqualifiers

Not meeting all of the inclusion criteria

Trial design

Treatments tested in this trial

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

Treatment groups

No treatment groups listed

Locations

1
Peking Union Medical College Hospital BeijingBeijing Municipality, China

Sponsors and collaborators

Lei Li

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution