Cervical Cytology DNA Methylation for Endometrial Lesion Screening and Follow-up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometrial Neoplasms, DNA Methylation, Cervical Smears, Early Detection of Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Study on Cervical Cytology DNA Methylation for Screening and Follow-up of Endometrial Lesions
Overview
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.
Primary outcome measures
- Sensitivity of CISENDO Test [Time frame: Baseline (at the time of initial hysteroscopy)]
Secondary outcome measures (5)
- Dynamic Change in DNA Methylation Level [Time frame: From baseline to 12 months]
- Positive and Negative Predictive Values of CISENDO Test [Time frame: Baseline]
- Diagnostic Accuracy (Area Under the ROC Curve) [Time frame: Baseline]
- Comparison of Screening Strategies [Time frame: Baseline]
- Association of Methylation Level with Risk Stratification [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07298707 · K9518 · ZS-2740