The Role of the Genital Tract Microbiota in Cervical Epithelial Cell DNA Methylation and the Increased Risk of Cervical Cancer Development
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Changes in DNA methylation of cervical epithelial cells
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Changes in DNA methylation of cervical epithelial cells
时间窗: Baseline (enrollment period)
Changes in DNA methylation of cervical epithelial cells
次要结局
- Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens(Baseline (enrollment period))
研究者
Muxuan Chen
Diagnostic Technician
Zhujiang Hospital