Uterine Cervical Cancer Clinical Trial
Official title:
Utilization of DNA Methylation in the Screening of Uterine Cervical Lesions: A Case-control Study
| 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 |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Lei Li | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Lei Li |
China,
| 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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