DNA Methylation and the Increased Risk of Cervical Cancer Development

Zhujiang Hospital

Status: Not yet enrolling

Conditions: Papillomavirus Infections; Cervical Cancer

Treatments: Other: Reproductive tract microbiota

Study type: Observational

Funder types: Other

Identifiers

NCT06859151

CALM2501

Details and patient eligibility

About

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

Full 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

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 4 patient groups

control

Description:

HPV16(-) HPV18(-) TCT(-)

Treatment:

Other: Reproductive tract microbiota

Case group 1

Description:

HPV16(+) /HPV18(+) TCT(-) CIN\<2

Treatment:

Other: Reproductive tract microbiota

Case group 2

Description:

HPV16(+) /HPV18(+) TCT(+) CIN\<2

Treatment:

Other: Reproductive tract microbiota

Case group 3

Description:

HPV16(+) /HPV18(+) TCT(+) CIN≥2+

Treatment:

Other: Reproductive tract microbiota