DNA Methylation and the Increased Risk of Cervical Cancer Development

Not yet recruiting

• Conditions: Cervical Cancer; Papillomavirus Infections

• Registration Number: NCT06859151
• Lead Sponsor: Zhujiang Hospital

Brief 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

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Study Start: 2025-03-20
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

1. Aged 18-50 years old, with a history of sexual activity
2. HPV and TCT tests are performed concurrently in the gynecology clinic
3. Those with abnormal HPV and TCT test results undergo tissue pathological testing

Exclusion Criteria

1. Pregnant or breastfeeding
2. Patients with immunological disorders or severe autoimmune diseases, such as AIDS, SLE
3. Those who have had organ transplants or are currently using immunosuppressive agents
4. Use of vaginal douching within 48 hours before sample collection
5. Use of vaginal probiotics within one month before sample collection
6. Use of vaginal antibiotics or antifungal treatments within one month before sample collection
7. History of surgery related to cervical intraepithelial neoplasia (CIN), including but not limited to conization of the cervix, LEEP procedures, etc.
8. Blood samples (avoid sampling during menstruation), insufficient remaining sample volume to support subsequent analysis needs, and samples not stored as required.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in DNA methylation of cervical epithelial cells	Baseline (enrollment period)	Changes in DNA methylation of cervical epithelial cells

Secondary Outcome Measures

Name	Time	Method
Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens	Baseline (enrollment period)	Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens.