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Cervical Cytology DNA Methylation for Endometrial Lesion Screening and Follow-up

NCT07298707 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3500

Last updated 2025-12-23

No results posted yet for this study

Summary

The goal of this observational study is to evaluate the accuracy of a novel molecular test for screening and monitoring endometrial lesions in women at medium-to-high risk for endometrial cancer.

The main questions it aims to answer are:

* What is the sensitivity and specificity of the CISENDO test (a DNA methylation test on cervical cytology samples) for detecting histologically confirmed endometrial intraepithelial neoplasia (EIN) or invasive endometrial cancer?
* How do DNA methylation levels change during the follow-up of endometrial lesions? Researchers will compare the results of the CISENDO test to the results from the standard diagnostic procedure (hysteroscopy with histology) to see if the molecular test can reliably identify high-risk lesions and track disease progression.

Participants will:

* Provide a residual liquid-based cervical cytology sample for the CISENDO test.
* Undergo a standard diagnostic hysteroscopy examination (with or without biopsy) for comparison.
* Some participants will return for follow-up visits at 6 and 12 months for repeat methylation testing and/or hysteroscopy to monitor their condition.

Conditions

  • Endometrial Neoplasms
  • DNA Methylation
  • Cervical Smears
  • Early Detection of Cancer
  • Endometrial Hyperplasia

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • Beijing Chuiyangliu Hospital

    collaborator OTHER_GOV

  • Beijing Sixth Hospital

    collaborator UNKNOWN

  • Peking Union Medical College Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-10
Primary Completion
2026-07-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07298707 on ClinicalTrials.gov