Clinical trial NCT06859151: DNA Methylation and the Increased Risk of Cervical Cancer Development
Official title: The Role of the Genital Tract Microbiota in Cervical Epithelial Cell DNA Methylation and the Increased Risk of Cervical Cancer Development
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer
Papillomavirus Infections
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 to 50

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

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in DNA methylation of cervical epithelial cells
timeFrame: Baseline (enrollment period)
Secondary outcomes:
measure: Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens
timeFrame: Baseline (enrollment period)
Other outcomes:
Locations:
Study officials:
affiliation: Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
name: Muxuan Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: