DNA MethylationNCT03961191
DNA Methylation for Screening Uterine Cervical Lesions: A Case-control Study
An observational study of DNA Methylation and Uterine Cervical Cancer, run by Lei Li at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- DNA Methylation, Uterine Cervical Cancer, High Grade Squamous Intraepithelial Lesions
- What is being tested?
- DNA methylation, high-risk HPV and TCT
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2019to 22 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 1. Wtih confirmed cervical histology within one month when collecting cervical cytology 2. Aged 18 years or older
Who may be able to join
- Confirmed cervical histology within one month when collecting cervical cytology
- Aged 18 years or older
- Signed an approved informed consents
Who cannot join
- Not meeting any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Utilization of DNA Methylation in the Screening of Uterine Cervical Lesions: A Case-control Study
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.
- Conditions
- DNA Methylation, Uterine Cervical Cancer, High Grade Squamous Intraepithelial Lesions, Low Grade Squamous Intraepithelial Lesions
- Being tested
- DNA methylation, high-risk HPV, TCT
- Medical subject headings
- Uterine Cervical Neoplasms, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylationDiagnostic test
DNA methylation for the cervical cytology
high-risk HPVDiagnostic test
High-risk HPV testing for the cervical cytology
TCTDiagnostic test
Thin prep liquid-based cytology test for the cervical cytology
| Study group | Role | What they receive |
|---|---|---|
| Benign group | Patients with benign cervical histology, including normal findings, inflammation and LSIL Receives: Diagnostic Test: DNA methylation; Diagnostic Test: high-risk HPV; Diagnostic Test: TCT | |
| HSIL group | Patients with cervical histology of HSIL Receives: Diagnostic Test: DNA methylation; Diagnostic Test: high-risk HPV; Diagnostic Test: TCT | |
| Cancer group | Patients with cervical histology of cancer Receives: Diagnostic Test: DNA methylation; Diagnostic Test: high-risk HPV; Diagnostic Test: TCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of DNA methylation
Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Measured: 1 years
Specificity of DNA methylation
Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Measured: 1 years
Secondary outcomes (3)
Positive predictive value of DNA methylation
Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Measured: 1 year
Negative predictive value of DNA methylation
Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Measured: 1 year
Correlation coefficient of DNA methylation with other screening methods
Correlation coefficient of DNA methylation with high-risk HPV and TCT results
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start22 May 2019
- Primary completion22 May 2020 (estimated)
- Study completion22 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNA MethylationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961191
- Sponsor's protocol ID
- METHY1
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of DNA Methylation in the Screening of Uterine Cervical Lesions: A Case-control Study
- ClinicalTrials.gov ID
- NCT03961191
- Acronym / sponsor ID
- METHY1
- Conditions
- DNA Methylation, Uterine Cervical Cancer, High Grade Squamous Intraepithelial Lesions, Low Grade Squamous Intraepithelial Lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 22 May 2020 (estimated)
- Study completion
- 22 May 2020 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Benign group | – | Diagnostic Test: DNA methylation, Diagnostic Test: high-risk HPV, Diagnostic Test: TCTPatients with benign cervical histology, including normal findings, inflammation and LSIL |
| HSIL group | – | Diagnostic Test: DNA methylation, Diagnostic Test: high-risk HPV, Diagnostic Test: TCTPatients with cervical histology of HSIL |
| Cancer group | – | Diagnostic Test: DNA methylation, Diagnostic Test: high-risk HPV, Diagnostic Test: TCTPatients with cervical histology of cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Wtih confirmed cervical histology within one month when collecting cervical cytology 2. Aged 18 years or older
Key inclusion criteria (3 listed)
- Confirmed cervical histology within one month when collecting cervical cytology
- Aged 18 years or older
- Signed an approved informed consents
Key exclusion criteria (1 listed)
- Not meeting any of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA methylationDNA methylation for the cervical cytology | Diagnostic test | Benign group, Cancer group, HSIL group |
| high-risk HPVHigh-risk HPV testing for the cervical cytology | Diagnostic test | Benign group, Cancer group, HSIL group |
| TCTThin prep liquid-based cytology test for the cervical cytology | Diagnostic test | Benign group, Cancer group, HSIL group |
Primary outcome
Sensitivity of DNA methylation
Time frame: 1 years
Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
Specificity of DNA methylation
Time frame: 1 years
Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL
3 secondary outcomes
Positive predictive value of DNA methylation
Time frame: 1 year
Negative predictive value of DNA methylation
Time frame: 1 year
Correlation coefficient of DNA methylation with other screening methods
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DNA Methylation and Uterine Cervical Cancer, run by Lei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D. (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of DNA methylation (time frame: 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.