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Cervical Cytology DNA Methylation for Cervical Cancer Screening: A Real Word Study
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Start Date
September 1, 2024
Primary Completion Date
October 1, 2026
Completion Date
October 1, 2026
Last Updated
August 19, 2024
30,000
ESTIMATED participants
human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m)
DIAGNOSTIC_TEST
Lead Sponsor
Lei Li
NCT06349642
NCT05639972
Data Source & Attribution
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