ClinicalTrials.gg
Active, not recruitingNCT07874529Updated Oct 15, 2026

Cervical Cytology DNA Methylation for Endometrial Cancer Screening

An observational study in Endometrial Cancer, DNA Methylation and Cytology, sponsored by Lei Li. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Lei Li · Observational

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30,000
Ages
18 Years and older
Sex
Female
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Study 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. 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.

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Conditions studied

  • Endometrial Cancer
  • DNA Methylation
  • Cytology
  • Cancer Screening
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In context

Endometrial Neoplasms

1,347 studies on the registry are indexed under Endometrial Neoplasms; 452 are open to participants now.

This study's planned enrollment of 30,000 is above the median of 200 across 328 observational studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Lei Li is the lead sponsor of 62 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All women asking for Collection of cervical exfoliated cells in hospital situation or in community situation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age is 18 years old or above.
  2. Agree to undergo the routine methylation test for endometrial cancer and participate in the study;
  3. The medical records are complete and include the results of endometrial tissue pathology examination.
  4. Be informed of the relevant risks of the project and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Did not meet all the inclusion criteria.
  2. Cancer of the female reproductive system under treatment (except for endometrial cancer);
  3. Active bleeding from the lower genital tract;
  4. Immunosuppressed state (such as after HIV infection, organ transplantation, etc.)
  5. Others (including those that the researchers deemed unsuitable for inclusion).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • Diagnostic testCDO1 and CELF4 gene methylation

    CDO1m and CELF4m for cervical cancer screening

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What researchers measure

Primary outcomes

  1. Number of participants with histopathological diagnosis of endometrial cancer

    Time frame: 1 year

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Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, 100730, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.

Of 126 non-industry observational studies under Endometrial Neoplasms, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 206. This study's planned 23 months is below that.

Counting every sponsor, half of 146 studies reached it within 66 months; a quarter within 32 and three quarters within 206.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 15, 2026
StartActual
Dec 12, 2025
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07874529
Lead sponsor
Lei Li
Responsible party
Lei Li (Professor, Peking Union Medical College Hospital) — Sponsor-investigator
First posted
Oct 15, 2026
Start date
Dec 12, 2025
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Oct 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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