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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03961191
Other study ID # METHY1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 22, 2019
Est. completion date May 22, 2020

Study information

Verified date May 2019
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone +8613911988831
Email lileigh@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 in a case-control study, so as to determine the accuracy of DNA methylation in the screening of uterine cervical lesions.

This study will include 300 patients with definite histological results, with 100 of cervical inflammation or low grade squamous intraepithelial lesions (LSIL), 100 of high grade squamous intraepithelial lesions (HSIL), and 100 of uterine cervical cancer. 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 May 22, 2020
Est. primary completion date May 22, 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 any 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 HSIL 1 years
Primary Specificity of DNA methylation Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL 1 years
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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