Cervical Cytology DNA Methylation for Cervical Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m).
- Who it may be relevant to
- Registry conditions: Cervical Cancer, DNA Methylation, Cytology, Human Papillomavirus Infection. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cervical Cytology DNA Methylation for Cervical Cancer Screening: A Real Word Study
Overview
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.
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
Primary outcome measures
- Number of participants with histopathological diagnosis of grade 2 cervical intraepithelial neoplasia (CIN) or worse (CIN2+) [Time frame: 1 year]
- Number of participants with histopathological diagnosis of grade 3 cervical intraepithelial neoplasia (CIN) or worse (CIN3+) [Time frame: 1 year]
Secondary outcome measures (1)
- Number of participants with histopathological diagnosis of invasive cervical carcinoma [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Aged 18 years or older
- With uterine cervix intact
- Given consents to participate the study
- With detailed follow-up outcomes
Exclusion criteria
- Not meeting all of the inclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06557954 · METHY5