DNA Methylation Testing for the Screening of Uterine Cervical Lesion

NCT04646954 | Unknown Phase 3

• 1 other identifier: METHY3
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

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

  Two years

Study Arms (1)

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

Host DNA methylation testing DIAGNOSTIC_TEST

Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample

Study group

Cervical cytology and/or high-risk human papillomavirus assays DIAGNOSTIC_TEST

Cervical cytology and/or high-risk human papillomavirus assays

Study group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831; lileigh@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: November 30, 2020
• Study Start: November 26, 2020
• Primary Completion: November 26, 2022
• Study Completion: November 26, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CN (1)