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NCT Number: NCT07298707

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

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.

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Key information

Conditions

Endometrial Neoplasms Cervical Smears DNA Methylation Early Detection of Cancer Endometrial Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be 18 years of age or older.
  • Participants must possess medium-to-high risk factors for endometrial cancer as defined by Chinese consensus guidelines and are scheduled for hysteroscopic evaluation; OR are currently undergoing conservative treatment (e.g., progesterone therapy or endometrial ablation) for endometrial lesions, and have not received chemotherapy.
  • Participants must be capable and willing to provide written informed consent.
  • Participants must be willing to undergo at least one follow-up assessment within 1 year.
  • Participants must have an intact cervix (a history of LEEP or conization is acceptable).

Exclusion criteria

  • Current treatment for any gynecologic malignancy other than endometrial cancer.
  • Current or untreated cervical, vaginal, or vulvar intraepithelial neoplasia or carcinoma.
  • History of total or subtotal hysterectomy, trachelectomy, radical trachelectomy, or pelvic radiotherapy.
  • Active lower genital tract bleeding.
  • Immunosuppressed state (e.g., HIV infection, status post organ transplantation).
  • Failure to undergo the planned hysteroscopic evaluation and follow-up within 1 year after the initial assessment.
  • Failed hysteroscopic procedure.
  • Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.

Treatment and study plan

Primary outcomes

  1. Sensitivity of CISENDO Test

    Time frame: Baseline (at the time of initial hysteroscopy)

    The proportion of participants with histologically confirmed endometrial intraepithelial neoplasia (EIN) or invasive endometrial cancer who have a positive CISENDO test result at baseline.

Secondary outcomes

  1. Dynamic Change in DNA Methylation Level

    Time frame: From baseline to 12 months

    The relative change in DNA methylation level (as measured by the CISENDO test) between baseline and follow-up visits (6 and 12 months) in participants undergoing surveillance.

  2. Positive and Negative Predictive Values of CISENDO Test

    Time frame: Baseline

    The probability that participants with a positive test result truly have the disease (PPV), and the probability that those with a negative result truly do not have the disease (NPV), using histology as the gold standard.

  3. Diagnostic Accuracy (Area Under the ROC Curve)

    Time frame: Baseline

    The overall diagnostic performance of the CISENDO test, evaluated by the Area Under the Receiver Operating Characteristic (ROC) Curve (AUC).

  4. Comparison of Screening Strategies

    Time frame: Baseline

    Comparison of diagnostic performance metrics (sensitivity, specificity, PPV, NPV) between the CISENDO test and traditional diagnostic pathways (e.g., ultrasound findings leading to hysteroscopy).

  5. Association of Methylation Level with Risk Stratification

    Time frame: Baseline

    The correlation between baseline DNA methylation levels and participants' clinical risk stratification according to Chinese consensus guidelines.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Lei, Professor

CONTACT

[email protected]

+86-139-1198-8831

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Beijing Chuiyangliu Hospital
  • Beijing Sixth Hospital
  • Beijing Tiantan Hospital
  • The Third Xiangya Hospital of Central South University

Registry information

Official study title

A Multicenter Study on Cervical Cytology DNA Methylation for Screening and Follow-up of Endometrial Lesions

Acronym: EndoMethy-V

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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