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DNA Methylation Testing for the Screening of Uterine Cervical Lesion

Sponsor
Lei Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT04646954
Collaborator
(none)
12,000
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
500.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Host DNA methylation testing
  • Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12000 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Multicenter, Prospective Cohort Study
Actual Study Start Date :
Nov 26, 2020
Anticipated Primary Completion Date :
Nov 26, 2022
Anticipated Study Completion Date :
Nov 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

All eligible participants are included in the study group

Diagnostic Test: Host DNA methylation testing
Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample

Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays
Cervical cytology and/or high-risk human papillomavirus assays

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy [Two years]

    The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lei Li Beijing Beijing China 100730

Sponsors and Collaborators

  • Lei Li

Investigators

  • Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT04646954
Other Study ID Numbers:
  • METHY3
First Posted:
Nov 30, 2020
Last Update Posted:
Nov 30, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Nov 30, 2020