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
1 other identifier
observational
2,000
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedStudy Start
First participant enrolled
March 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
ExpectedMarch 5, 2025
February 1, 2025
10 months
February 27, 2025
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in DNA methylation of cervical epithelial cells
Changes in DNA methylation of cervical epithelial cells
Baseline (enrollment period)
Secondary Outcomes (1)
Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens
Baseline (enrollment period)
Study Arms (4)
control
HPV16(-) HPV18(-) TCT(-)
Case group 1
HPV16(+) /HPV18(+) TCT(-) CIN\<2
Case group 2
HPV16(+) /HPV18(+) TCT(+) CIN\<2
Case group 3
HPV16(+) /HPV18(+) TCT(+) CIN≥2+
Interventions
Reproductive tract microbiota
Eligibility Criteria
Women aged 18 to 50
You may qualify if:
- Aged 18-50 years old, with a history of sexual activity
- HPV and TCT tests are performed concurrently in the gynecology clinic
- Those with abnormal HPV and TCT test results undergo tissue pathological testing
You may not qualify if:
- Pregnant or breastfeeding
- Patients with immunological disorders or severe autoimmune diseases, such as AIDS, SLE
- Those who have had organ transplants or are currently using immunosuppressive agents
- Use of vaginal douching within 48 hours before sample collection
- Use of vaginal probiotics within one month before sample collection
- Use of vaginal antibiotics or antifungal treatments within one month before sample collection
- History of surgery related to cervical intraepithelial neoplasia (CIN), including but not limited to conization of the cervix, LEEP procedures, etc.
- Blood samples (avoid sampling during menstruation), insufficient remaining sample volume to support subsequent analysis needs, and samples not stored as required.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Biospecimen will include vaginal swabs, cervical exfoliated cells from reproductive tract of the volunteers
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muxuan Chen, Doctor
Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Diagnostic Technician
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 5, 2025
Study Start
March 20, 2025
Primary Completion
December 30, 2025
Study Completion (Estimated)
December 30, 2026
Last Updated
March 5, 2025
Record last verified: 2025-02