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Trial Title:
Cervical Cytology DNA Methylation for Cervical Cancer Screening
NCT ID:
NCT06557954
Condition:
Cervical Cancer
DNA Methylation
Cytology
Human Papillomavirus Infection
Cervical Intraepithelial Neoplasia
Cancer Screening
Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m)
Description:
PAX1m/JAM3m, with or without HPV testing and cytological pathology for cervical cancer
screening
Other name:
HPV testing
Other name:
cytological pathology
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.
Criteria for eligibility:
Study pop:
All women asking for cervical cancer screening in hospital situation or in community
situationg
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Start date:
September 1, 2024
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Lei Li
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06557954
