NCT06859151

DNA Methylation and the Increased Risk of Cervical Cancer Development

The Role of the Genital Tract Microbiota in Cervical Epithelial Cell DNA Methylation and the Increased Risk of Cervical Cancer Development

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate the correlation between reproductive tract microbiota and DNA methylation in cervical epithelial cells, as well as its impact on the development of cervical cancer, through a paired case-control clinical study

Detailed description

This study is a multicenter matched case-control study. The inclusion and exclusion criteria are verified by collecting HPV test results, TCT examination results, and for the case group, participants' histopathological results are also collected. Participants who meet the inclusion and exclusion criteria have their HPV DNA test original secretion samples and TCT examination original cervical scrape cell samples (preserved in RNA preservative solution) collected. Enrollment involves dividing the samples into a discovery cohort of 800 cases and a validation cohort of 1200 cases. The discovery cohort undergoes multi-target DNA methylation testing, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing; the validation cohort undergoes PCR validation of DNA methylation sites related to cervical cancer, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing

Conditions

• Cervical Cancer
• Papillomavirus Infections

Interventions

Type	Name	Description
OTHER	Reproductive tract microbiota	Reproductive tract microbiota

Timeline

• Start date: 2025-03-20
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2025-03-05
• Last updated: 2025-03-05