Cervical CancerNCT05290428
DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening
An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation
- What is being tested?
- DNA methylation testing
- How many people
- 459 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2022to 12 Dec 2022
- 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: All participants will accept surgeries harvesting cervical histology.
Who may be able to join
- With uterine cervix intact
- Aged 18 years or older
- With accessible histological results of cervix
- Signed an approved informed consents
- With accessible cervical cytology before harvesting cervical histology
Who cannot join
- Not meeting all 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, 8613911988831, lileigh@163.com
About this study
Official title: The Accuracy of Host DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials
Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation, Cancer Screening, Detection Accuracy
- Being tested
- DNA methylation testing
- 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.
DNA methylation testingDiagnostic test
All cervical cytology samples will be tested for PAX1 and JAM3 methylation
| Study group | Role | What they receive |
|---|---|---|
| Retrospective part | This part will enroll at least 120 cases in previously preserved samples. Receives: Diagnostic Test: DNA methylation testing | |
| Prospective part | This part will enroll at least 339 cases. Receives: Diagnostic Test: DNA methylation testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of methylation testing
Sensitivity of methylation testing of cervical cytology compared with histology
Measured: One week
Specificity of methylation testing
Specificity of methylation testing of cervical cytology compared with histology
Measured: One week
Secondary outcomes (2)
Positive predictive value of methylation testing
Positive predictive value of methylation testing of cervical cytology compared with histology
Measured: One week
Negative predictive value of methylation testing
Negative predictive value of methylation testing of cervical cytology compared with histology
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start12 Mar 2022
- Primary completion12 Sep 2022 (estimated)
- Study completion12 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 459 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal 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
- NCT05290428
- Sponsor's protocol ID
- METHY4
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2022
- Last updated
- 22 Mar 2022
- 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 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Host DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials
- ClinicalTrials.gov ID
- NCT05290428
- Acronym / sponsor ID
- METHY4
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia, DNA Methylation, Cancer Screening, Detection Accuracy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 459 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 12 Sep 2022 (estimated)
- Study completion
- 12 Dec 2022 (estimated)
- First posted
- 22 Mar 2022 (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.
Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective part | – | Diagnostic Test: DNA methylation testingThis part will enroll at least 120 cases in previously preserved samples. |
| Prospective part | – | Diagnostic Test: DNA methylation testingThis part will enroll at least 339 cases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will accept surgeries harvesting cervical histology.
Key inclusion criteria (5 listed)
- With uterine cervix intact
- Aged 18 years or older
- With accessible histological results of cervix
- Signed an approved informed consents
- With accessible cervical cytology before harvesting cervical histology
Key exclusion criteria (1 listed)
- Not meeting all 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 methylation testingAll cervical cytology samples will be tested for PAX1 and JAM3 methylation | Diagnostic test | Prospective part, Retrospective part |
Primary outcome
Sensitivity of methylation testing
Time frame: One week
Sensitivity of methylation testing of cervical cytology compared with histology
Specificity of methylation testing
Time frame: One week
Specificity of methylation testing of cervical cytology compared with histology
2 secondary outcomes
Positive predictive value of methylation testing
Time frame: One week
Negative predictive value of methylation testing
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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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 Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Peking Union Medical College Hospital 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 5 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 22 Mar 2022. 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 Lie Li, M.D. (10-139-1198-8831, 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 methylation testing (time frame: One week). 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 22 Mar 2022.