Cervical CancerPhase 3NCT04646954
DNA Methylation Testing for the Screening of Uterine Cervical Lesion
A Phase 3 study testing Host DNA methylation testing and Cervical cytology and/or high-risk human papillomavirus assays in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Lei Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation
- What is being tested?
- Host DNA methylation testing and Cervical cytology and/or high-risk human papillomavirus assays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2020to 26 Nov 2022
- Phase
- Phase 3
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21 years or older
- Signed an approved informed consents
- Feasible to be followed up
- Available residual cytology samples for methylation analysis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 8613911988831, lileigh@163.com
About this study
Official title: DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Multicenter, Prospective Cohort Study
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
- Being tested
- Host DNA methylation testing, Cervical cytology and/or high-risk human papillomavirus assays
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Host DNA methylation testingDiagnostic test
Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample
Cervical cytology and/or high-risk human papillomavirus assaysDiagnostic test
Cervical cytology and/or high-risk human papillomavirus assays
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | All eligible participants are included in the study group Receives: Diagnostic Test: Host DNA methylation testing; Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start26 Nov 2020
- Primary completion26 Nov 2022 (estimated)
- Study completion26 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。
- Masking
- None (open label)
- Enrolment
- 12,000 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
- NCT04646954
- Sponsor's protocol ID
- METHY3
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kong L, Xiao X, Wu H, You Y, Jin X, Liou Y, Liu P, Lang J, Li L. Triage performance of DNA methylation for women with high-risk human papillomavirus infection. Oncologist. 2025 Mar 10;30(3):oyae324. doi: 10.1093/oncolo/oyae324.
PubMed 39603822
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04646954
- Acronym / sponsor ID
- METHY3
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation, High-risk Human Papillomavirus, Cytology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 26 Nov 2022 (estimated)
- Study completion
- 26 Nov 2022 (estimated)
- First posted
- 30 Nov 2020 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: Host DNA methylation testing, Diagnostic Test: Cervical cytology and/or high-risk human papillomavirus assaysAll eligible participants are included in the study group |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 21 years or older
- Signed an approved informed consents
- Feasible to be followed up
- Available residual cytology samples for methylation analysis
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Host DNA methylation testingHost EPB41L3, JAM3 and PAX1 methylation testing by cytology sample | Diagnostic test | Study group |
| Cervical cytology and/or high-risk human papillomavirus assaysCervical cytology and/or high-risk human papillomavirus assays | Diagnostic test | Study group |
Primary outcome
Diagnostic accuracy
Time frame: Two years
The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Derived from this study: PubMed 39603822Kong L, Xiao X, Wu H, You Y, Jin X, Liou Y, Liu P, Lang J, Li L. Triage performance of DNA methylation for women with high-risk human papillomavirus infection. Oncologist. 2025 Mar 10;30(3):oyae324. doi: 10.1093/oncolo/oyae324.
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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?
A Phase 3 study testing Host DNA methylation testing and Cervical cytology and/or high-risk human papillomavirus assays in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, 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 4 inclusion and 2 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 30 Nov 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Diagnostic accuracy (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646954, which also lists 1 linked publication.
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 30 Nov 2020.