Cervical Cytology DNA Methylation for Cervical Cancer Screening

Not yet recruiting

• Conditions: Cervical Intraepithelial Neoplasia; Cancer Screening; DNA Methylation; Cervical Cancer; Cytology; Human Papillomavirus Infection

• Registration Number: NCT06557954
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-19
• Study Start: 2024-09-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with histopathological diagnosis of grade 2 cervical intraepithelial neoplasia (CIN) or worse (CIN2+)	1 year	Including CIN2, CIN3, adenocarcinoma in situ and invasive cervical carcinoma
Number of participants with histopathological diagnosis of grade 3 cervical intraepithelial neoplasia (CIN) or worse (CIN3+)	1 year	Including CIN3, adenocarcinoma in situ and invasive cervical carcinoma

Secondary Outcome Measures

Name	Time	Method
Number of participants with histopathological diagnosis of invasive cervical carcinoma	1 year	Including invasive cervical carcinoma of various subtypes

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China