DNA Methylation and the Increased Risk of Cervical Cancer Development

NCT ID: NCT06859151

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-12-30

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

Conditions

Cervical Cancer; Papillomavirus Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

control

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

Reproductive tract microbiota

Intervention Type: OTHER

Reproductive tract microbiota

Case group 1

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

Reproductive tract microbiota

Intervention Type: OTHER

Reproductive tract microbiota

Case group 2

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

Reproductive tract microbiota

Intervention Type: OTHER

Reproductive tract microbiota

Case group 3

HPV16(+) /HPV18(+) TCT(+) CIN≥2+

Reproductive tract microbiota

Intervention Type: OTHER

Reproductive tract microbiota

Interventions

Reproductive tract microbiota

Reproductive tract microbiota

Intervention Type: OTHER

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Muxuan Chen

Diagnostic Technician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muxuan Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University

Central Contacts

Muxuan Chen, Doctor

Role: CONTACT

muxuanchen@126.com

+8613580561916

Other Identifiers

CALM2501

Identifier Type: -

Identifier Source: org_study_id