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NCT03960879 Clinical Trial

DNA Methylation for Screening Uterine Cervical Lesions

Uterine Cervical Cancer Clinical Trial

Official title:
DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03960879
Other study ID # METHY2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date June 1, 2020

Study information
Verified date May 2019
Source Peking Union Medical College Hospital
Contact Lei Li
Phone +8613911988831
Email lilei@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study.

This study will include 300 unselected patients with definite histological results. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.

The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Confirmed cervical histology within one month when collecting cervical cytology

- Aged 18 years or older

- Signed an approved informed consents

Exclusion Criteria:

- Not meeting all of the inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DNA methylation
DNA methylation for the cervical cytology
• High-risk HPV
High-risk HPV testing for the cervical cytology
• TCT
Thin prep liquid-based cytology test for the cervical cytology

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of DNA methylation Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL) 1 year
Primary Specificity of DNA methylation Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL 1 year
Secondary Positive predictive value of DNA methylation Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL 1 year
Secondary Negative predictive value of DNA methylation Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL 1 year
Secondary Correlation coefficient of DNA methylation with other screening methods Correlation coefficient of DNA methylation with high-risk HPV and TCT results 1 year
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