Endometrial CancerNCT07874529
Cervical Cytology DNA Methylation for Endometrial Cancer Screening
An observational study of Endometrial Cancer and DNA Methylation, run by Lei Li at 1 site in China.
Trial summary
This study intends to conduct the "Real-world Study on Cervical Cytology Methylation Testing for Endometrial Cancer Screening" project through a multi-center real-world research approach. Led by Peking Union Medical College Hospital, at least 10 institutions will participate in the study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, DNA Methylation, Cytology
- What is being tested?
- CDO1 and CELF4 gene methylation
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to 1 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 women asking for Collection of cervical exfoliated cells in hospital situation or in community situation
Who may be able to join
- Age is 18 years old or above.
- Agree to undergo the routine methylation test for endometrial cancer and participate in the study;
- The medical records are complete and include the results of endometrial tissue pathology examination.
- Be informed of the relevant risks of the project and voluntarily sign the informed consent form.
Who cannot join
- Did not meet all the inclusion criteria.
- Cancer of the female reproductive system under treatment (except for endometrial cancer);
- Active bleeding from the lower genital tract;
- Immunosuppressed state (such as after HIV infection, organ transplantation, etc.)
- Others (including those that the researchers deemed unsuitable for inclusion).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-world Study on the Use of Cervical Cytology Methylation Testing for the Screening of Endometrial Cancer
This study intends to conduct the "Real-world Study on Cervical Cytology Methylation Testing for Endometrial Cancer Screening" project through a multi-center real-world research approach. Led by Peking Union Medical College Hospital, at least 10 institutions will participate in the study. The goal is to complete the enrollment of at least 30 million real-world samples. Focusing on the changes in DNA methylation levels in cervical exfoliated cells as the research entry point, this study aims to provide new ideas and theoretical basis for preventing and treating endometrial cancer by targeting the CDO1/CELF4 double gene methylation. The expectation is to achieve the clinical application of a more optimal endometrial cancer screening protocol, improve the current shortcomings of endometrial cancer screening, make endometrial cancer screening more accurate, effectively reduce the incidence of endometrial cancer, and avoid excessive medical treatment.
- Conditions
- Endometrial Cancer, DNA Methylation, Cytology, Cancer Screening
- Being tested
- CDO1 and CELF4 gene methylation
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDO1 and CELF4 gene methylationDiagnostic test
CDO1m and CELF4m for cervical cancer screening
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with histopathological diagnosis of endometrial cancer
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 posted15 Oct 2026
- Study start12 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874529
- Sponsor's protocol ID
- K9733
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study on the Use of Cervical Cytology Methylation Testing for the Screening of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07874529
- Acronym / sponsor ID
- K9733
- Conditions
- Endometrial Cancer, DNA Methylation, Cytology, Cancer Screening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Oct 2026 (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.
This study intends to conduct the "Real-world Study on Cervical Cytology Methylation Testing for Endometrial Cancer Screening" project through a multi-center real-world research approach. Led by Peking Union Medical College Hospital, at least 10 institutions will participate in the study. The goal is to complete the enrollment of at least 30 million real-world samples. Focusing on the changes in DNA methylation levels in cervical exfoliated cells as the research entry point, this study aims to provide new ideas and theoretical basis for preventing and treating endometrial cancer by targeting the CDO1/CELF4 double gene methylation. The expectation is to achieve the clinical application of a more optimal endometrial cancer screening protocol, improve the current shortcomings of endometrial cancer screening, make endometrial cancer screening more accurate, effectively reduce the incidence of endometrial cancer, and avoid excessive medical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women asking for Collection of cervical exfoliated cells in hospital situation or in community situation
Key inclusion criteria (4 listed)
- Age is 18 years old or above.
- Agree to undergo the routine methylation test for endometrial cancer and participate in the study;
- The medical records are complete and include the results of endometrial tissue pathology examination.
- Be informed of the relevant risks of the project and voluntarily sign the informed consent form.
Key exclusion criteria (5 listed)
- Did not meet all the inclusion criteria.
- Cancer of the female reproductive system under treatment (except for endometrial cancer);
- Active bleeding from the lower genital tract;
- Immunosuppressed state (such as after HIV infection, organ transplantation, etc.)
- Others (including those that the researchers deemed unsuitable for inclusion).
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 |
|---|---|---|
| CDO1 and CELF4 gene methylationCDO1m and CELF4m for cervical cancer screening | Diagnostic test | – |
Primary outcome
Number of participants with histopathological diagnosis of endometrial cancer
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Endometrial Cancer and DNA Methylation, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with histopathological diagnosis of endometrial cancer (time frame: 1 year). 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 15 Oct 2026.