DNA Methylation and the Increased Risk of Cervical Cancer Development
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reproductive tract microbiota.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Papillomavirus Infections. Basic parameters: 15 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of the Genital Tract Microbiota in Cervical Epithelial Cell DNA Methylation and the Increased Risk of Cervical Cancer Development
Overview
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
Interventions
- Other Reproductive tract microbiota
Reproductive tract microbiota
Primary outcome measures
- Changes in DNA methylation of cervical epithelial cells [Time frame: Baseline (enrollment period)]
Secondary outcome measures (1)
- Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens [Time frame: Baseline (enrollment period)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06859151 · CALM2501