DNA Methylation and the Increased Risk of Cervical Cancer... | NCT06859151

Studies
DNA Methylation and the Increased Risk of Cervical Cancer Development

NCT06859151

Sponsor

Zhujiang Hospital

Status

Not yet recruiting

Last Update Posted

Mar 5, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Cervical Cancer
Papillomavirus Infections

Interventions

Reproductive tract microbiota

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2025Estimated

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Feb 27, 2025

First Submission Date that Met QC Criteria

Mar 4, 2025

First Posted Date

Mar 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2025

Last Update Posted Date

Mar 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
control	HPV16(-) HPV18(-) TCT(-)	Other: Reproductive tract microbiota
Case group 1	HPV16(+) /HPV18(+) TCT(-) CIN<2	Other: Reproductive tract microbiota
Case group 2	HPV16(+) /HPV18(+) TCT(+) CIN<2	Other: Reproductive tract microbiota
Case group 3	HPV16(+) /HPV18(+) TCT(+) CIN≥2+	Other: Reproductive tract microbiota

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reproductive tract microbiota	Other	Reproductive tract microbiota	Case group 1 Case group 2 Case group 3 control

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Women aged 18 to 50

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Muxuan Chen, Doctor	Contact	+8613580561916		muxuanchen@126.com

Overall Officials

Name	Affiliation	Role
Muxuan Chen, Doctor	Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D030361	Papillomavirus Infections

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

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Browse Branches

Not provided