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
This trial does not accept healthy volunteersQualifiers
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 population
All women asking for cervical cancer screening in hospital situation or in community situationg
Trial design
Cohort
Retrospective
Treatments tested in this trial
human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m)
Diagnostic testPAX1m/JAM3m, with or without HPV testing and cytological pathology for cervical cancer screening
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with histopathological diagnosis of grade 2 cervical intraepithelial neoplasia (CIN) or worse (CIN2+)
Including CIN2, CIN3, adenocarcinoma in situ and invasive cervical carcinoma
Number of participants with histopathological diagnosis of grade 3 cervical intraepithelial neoplasia (CIN) or worse (CIN3+)
Including CIN3, adenocarcinoma in situ and invasive cervical carcinoma
Secondary outcomes
Number of participants with histopathological diagnosis of invasive cervical carcinoma
Including invasive cervical carcinoma of various subtypes
Sponsors and contacts
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Lei Li
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
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