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NCT Number: NCT06557954

Cervical Cytology DNA Methylation for Cervical Cancer Screening

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.

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Key information

Conditions

Cervical Cancer Cancer Screening Cervical Intraepithelial Neoplasia Communicable Diseases Cytology DNA Methylation DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: HPV testing, cytological pathology

Primary outcomes

  1. Number of participants with histopathological diagnosis of grade 2 cervical intraepithelial neoplasia (CIN) or worse (CIN2+)

    Time frame: 1 year

    Including CIN2, CIN3, adenocarcinoma in situ and invasive cervical carcinoma

  2. Number of participants with histopathological diagnosis of grade 3 cervical intraepithelial neoplasia (CIN) or worse (CIN3+)

    Time frame: 1 year

    Including CIN3, adenocarcinoma in situ and invasive cervical carcinoma

Secondary outcomes

  1. Number of participants with histopathological diagnosis of invasive cervical carcinoma

    Time frame: 1 year

    Including invasive cervical carcinoma of various subtypes

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Li, M.D.

CONTACT

[email protected]

86-139-1198-8831

Sponsors and collaborators

Lead sponsor

Lei Li

Other

Registry information

Official study title

Cervical Cytology DNA Methylation for Cervical Cancer Screening: A Real Word Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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