DNA Methylation and the Increased Risk of Cervical Cancer Development

March 4, 2025 updated by: Muxuan Chen, Zhujiang Hospital

The Role of the Genital Tract Microbiota in Cervical Epithelial Cell DNA Methylation and the Increased Risk of Cervical Cancer Development

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women aged 18 to 50

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
HPV16(-) HPV18(-) TCT(-)
Other: Reproductive tract microbiota
Reproductive tract microbiota
Case group 1
HPV16(+) /HPV18(+) TCT(-) CIN<2
Other: Reproductive tract microbiota
Reproductive tract microbiota
Case group 2
HPV16(+) /HPV18(+) TCT(+) CIN<2
Other: Reproductive tract microbiota
Reproductive tract microbiota
Case group 3
HPV16(+) /HPV18(+) TCT(+) CIN≥2+
Other: Reproductive tract microbiota
Reproductive tract microbiota

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in DNA methylation of cervical epithelial cells
Time Frame: Baseline (enrollment period)
Changes in DNA methylation of cervical epithelial cells
Baseline (enrollment period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens.
Baseline (enrollment period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Muxuan Chen, Doctor, Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALM2501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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