Cervical Cytology DNA Methylation for Cervical Cancer Screening

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorLei Li

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 volunteers

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 population

All women asking for cervical cancer screening in hospital situation or in community situationg

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

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

    Diagnostic test

    PAX1m/JAM3m, with or without HPV testing and cytological pathology for cervical cancer screening

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
1 year
2

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

Time frame
1 year

Secondary outcomes

1

Number of participants with histopathological diagnosis of invasive cervical carcinoma

Including invasive cervical carcinoma of various subtypes

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lei Li

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: