DNA Methylation Testing for the Screening of Uterine Cerv... | NCT04646954

Studies
DNA Methylation Testing for the Screening of Uterine Cervical Lesion

NCT04646954

Sponsor

Lei Li

Status

Unknown status

Last Update Posted

Nov 30, 2020Actual

Enrollment

12,000Estimated

Phase

Phase 3

Conditions

Cervical Cancer
Cervical Intraepithelial Neoplasia
DNA Methylation
High-risk Human Papillomavirus
Cytology

Interventions

Host DNA methylation testing
Cervical cytology and/or high-risk human papillomavirus assays

Countries

China

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 26, 2020Actual

Primary Completion Date

Nov 26, 2022Estimated

Completion Date

Nov 26, 2022Estimated

First Submitted Date

Nov 25, 2020

First Submission Date that Met QC Criteria

Nov 25, 2020

First Posted Date

Nov 30, 2020Actual

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

Nov 25, 2020

Last Update Posted Date

Nov 30, 2020Actual

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

In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	All eligible participants are included in the study group	Diagnostic Test: Host DNA methylation testing Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Host DNA methylation testing	Diagnostic Test	Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.	Two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 21 years or older
Signed an approved informed consents
Feasible to be followed up
Available residual cytology samples for methylation analysis

Exclusion Criteria:

Without history of cervical disease, including cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
No requirement of cervical cancer screening of cytology or high-risk human papillomavirus

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Li, M.D.	Contact	+8613911988831		lileigh@163.com

Overall Officials

Name	Affiliation	Role
Lei Li, M.D.	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lei Li	Recruiting	Beijing	Beijing Municipality	100730	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39603822	Derived	Kong L, Xiao X, Wu H, You Y, Jin X, Liou Y, Liu P, Lang J, Li L. Triage performance of DNA methylation for women with high-risk human papillomavirus infection. Oncologist. 2025 Mar 10;30(3):oyae324. doi: 10.1093/oncolo/oyae324.

ID	Term
D002583	Uterine Cervical Neoplasms
D002578	Uterine Cervical Dysplasia

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